Company · US

Smiths Medical PM, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2009. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

49recalls (0 in 12 months)

48recalls that name a 510(k)

Product codes

Code	Device	Records
DPS	Electrocardiograph	38
DQA	Oximeter	9
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	3
BTL	Ventilator, Emergency, Powered (Resuscitator)	2
DXN	System, Measurement, Blood-Pressure, Non-Invasive	1
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
May 1, 2009	K083557	BCI WW1030 PULSE OXIMETER Smiths Medical Pm, Inc.	DQA
Apr 28, 2009	K090205	BCI WW1021 PC APPLICATION Smiths Medical Pm, Inc.	DQA
Apr 15, 2009	K083787	BCI WW1000 PULSE OXIMETER, MODEL WW1000 Smiths Medical Pm, Inc.	DQA
Apr 9, 2009	K083705	BCI WW1020 PULSE OXIMETER, MODEL WW1020 Smiths Medical Pm, Inc.	DQA
Jul 9, 2007	K070732	BCI AUTOCON 3304 DIGITAL PULSE OXIMETER Smiths Medical Pm, Inc.	DQA

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Mar 2, 2010	Smiths Medical PM, Inc. 8400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main St, Westfield, PA 16950) for its battery charger 330. Terminated	CCK	K991086
Mar 2, 2010	Smiths Medical PM, Inc. BCI 3180 Pulse Oximeter uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 E. Main St., Westfield, PA 16950). Terminated	DQA	K020350
Mar 2, 2010	Smiths Medical PM, Inc. 9200 Advisor Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 Main St., Westfield, PA 16950). Terminated	CCK	K030407
May 15, 2009	Smiths Medical PM, Inc. Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335, 925457325, 9254743 Terminated	CCK	K010770 K011177 +2
Aug 25, 2008	Smiths Medical PM, Inc. BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004, Terminated	DXN	K031742 K970801 +2
Aug 15, 2008	Smiths Medical PM, Inc. BCI 3180 Oximeter - Patient monitoring medical device, Manufactured by Smiths Medical PM, Inc. For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. Terminated	DQA	K020350
Sep 21, 2007	Smiths Medical PM, Inc. BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc Terminated	DQA	K981939
Jul 23, 2007	Smiths Medical PM, Inc. BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200) Terminated	MWI	K010770 K030407 +1
Jul 4, 2007	Smiths Medical PM, Inc. Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are intended for emergency resuscitation by medical personnel, p Terminated	BTL	K051322
Dec 19, 2006	Smiths Medical PM, Inc. BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system fea Terminated	DQA	K981939
Jan 24, 2006	Smiths Medical PM, Inc. Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of p Terminated	BTL	None listed
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 92E654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 92D754335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 92D654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 925754325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 925754225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 925754220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 925674325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 925654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 925654320, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 925534325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 925474335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 925454335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 925454325, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 925454220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 920754235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 920655235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 920654335, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 920654230, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
Nov 30, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200), catalog number 920634235, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002 Terminated	DPS	K010770 K011177 +2
May 12, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 92E654325. Terminated	DPS	K010770 K011177 +2
May 12, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925774325. Terminated	DPS	K010770 K011177 +2
May 12, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335. Terminated	DPS	K010770 K011177 +2
May 12, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674335. Terminated	DPS	K010770 K011177 +2
May 12, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674320. Terminated	DPS	K010770 K011177 +2
May 12, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325. Terminated	DPS	K010770 K011177 +2
May 12, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654220. Terminated	DPS	K010770 K011177 +2
May 12, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925574325. Terminated	DPS	K010770 K011177 +2
May 12, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925554325. Terminated	DPS	K010770 K011177 +2
May 12, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925474325. Terminated	DPS	K010770 K011177 +2
May 12, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654335. Terminated	DPS	K010770 K011177 +2
May 12, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225. Terminated	DPS	K010770 K011177 +2
Feb 10, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor model 9200, catalog number 925474325. Item Description 9200II 3LD/RP/SO/O2/IP/TP BMDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration Terminated	DPS	K011177 K030407 +1
Feb 10, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description 9200II 3LD/RP/O2/IP/TP/PR/B ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration Terminated	DPS	K011177 K030407 +1
Feb 10, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor model 9200, catalog number 92E654325. Item Description 9200 II 3LD/RP/O2/IP/TP/BATT ME. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiratio Terminated	DPS	K011177 K030407 +1
Feb 10, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor model 9200, catalog number 92E654220. item Description 9200 II 3LD/RSP/SP02 MDD MEDEXL. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiratio Terminated	DPS	K011177 K030407 +1
Feb 10, 2005	Smiths Medical PM, Inc. Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiratio Terminated	DPS	K011177 K030407 +1

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