Company ยท US
Nellcor Puritan Bennett, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2007. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQA | Oximeter | 23 |
| CBK | Ventilator, Continuous, Facility Use | 8 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 3 |
| BZD | Ventilator, Non-Continuous (Respirator) | 3 |
| DPS | Electrocardiograph | 2 |
| DWJ | System, Thermal Regulating | 2 |
| LRK | Device, Anti-Snoring | 2 |
| MNR | Ventilatory Effort Recorder | 2 |
| --- | 1 | |
| BSR | Stylet, Tracheal Tube | 1 |
| BZG | Spirometer, Diagnostic | 1 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| JDH | Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 |
| NLF | Oximeter, Reprocessed | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 13, 2007 | K070899 | PURITAN BENNETT LEGENDAIR XL2 Nellcor Puritan Bennett | CBK |
| May 25, 2007 | K070408 | DURAMAX REUSABLE OXIMETRY SENSOR Nellcor Puritan Bennett, Inc. | DQA |
| Aug 14, 2006 | K060576 | NELLCOR OXIMAX N-600X PULSE OXIMETER Nellcor Puritan Bennett, Inc. | DQA |
| Jan 10, 2006 | K051271 | OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR Nellcor Puritan Bennett, Inc. | DQA |
| Nov 10, 2005 | K052186 | NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P Nellcor Puritan Bennett, Inc. | DQA |
| Aug 11, 2005 | K051352 | OXIMAX NPB-40 HANDHELD PULSE OXIMETER Nellcor Puritan Bennett, Inc. | DQA |
| Jun 13, 2005 | K050072 | GOODKNIGHT 425ST Nellcor Puritan Bennett, Inc. | BZD |
| Dec 13, 2004 | K033973 | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR Nellcor Puritan Bennett, Inc. | NLF |
| Nov 14, 2003 | K030787 | SHILEY FLEXTRA TRACHEOSTOMY TUBE Nellcor Puritan Bennett, Inc. | JOH |
| May 23, 2003 | K030930 | OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N Nellcor Puritan Bennett, Inc. | DQA |
| Feb 7, 2003 | K023494 | NELLCOR INDGO MANUAL RESUSCITATOR Nellcor Puritan Bennett, Inc. | BTM |
| Sep 24, 2002 | K022819 | NELLCOR N-200 PULSE OXIMETER, MODEL N-200 Nellcor Puritan Bennett, Inc. | DQA |
| Aug 7, 2002 | K020357 | 800 SERIES EASYNEB NEBULIZER Nellcor Puritan Bennett, Inc. | CAF |
| Jun 19, 2002 | K021089 | OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR Nellcor Puritan Bennett, Inc. | DQA |
| May 8, 2002 | K021090 | OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER Nellcor Puritan Bennett, Inc. | DQA |
| Apr 23, 2002 | K020604 | WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 Nellcor Puritan Bennett, Inc. | DWJ |
| Mar 7, 2002 | K012891 | OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) Nellcor Puritan Bennett, Inc. | DQA |
| Jan 11, 2002 | K014121 | WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 Nellcor Puritan Bennett, Inc. | DWJ |
| Oct 18, 2000 | K002686 | ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E Nellcor Puritan Bennett, Inc. | CBK |
| Nov 24, 1999 | K993637 | N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS Nellcor Puritan Bennett, Inc. | DQA |
| Nov 18, 1999 | K990177 | NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR Nellcor Puritan Bennett, Inc. | CBK |
| Aug 25, 1999 | K991823 | N-395 PULSE OXIMETER, MODEL N-395 Nellcor Puritan Bennett, Inc. | DQA |
| Aug 18, 1999 | K990565 | SUZANNE Nellcor Puritan Bennett, Inc. | MNR |
| Dec 9, 1998 | K983274 | STARTRACK INFANT GRAPHICS MONITOR Nellcor Puritan Bennett, Inc. | BZK |
| Dec 7, 1998 | K982728 | NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C Nellcor Puritan Bennett, Inc. | DQA |
| Jul 22, 1998 | K980365 | GOODKNIGHT 418 CPAP SYSTEM Nellcor Puritan Bennett, Inc. | BZD |
| Apr 30, 1998 | K980441 | SPIROMETER MODEL NPB-500 Nellcor Puritan Bennett, Inc. | BZG |
| Mar 25, 1998 | K973419 | DMR PLUS DISPOSABLE MANUAL RESUSCITATOR Nellcor Puritan Bennett, Inc. | BTM |
| Nov 14, 1997 | K973147 | NPB-295 PULSE OXIMETER Nellcor Puritan Bennett, Inc. | DQA |
| Oct 21, 1997 | K972837 | NPB-290 PULSE OXIMETER (NPB-290) Nellcor Puritan Bennett, Inc. | DQA |
| Sep 25, 1997 | K972468 | NPB-195 PULSE OXIMETER Nellcor Puritan Bennett, Inc. | DQA |
| Sep 12, 1997 | K972248 | NELLCOR PURITAN BENNETT GEMINI Nellcor Puritan Bennett, Inc. | CBK |
| Aug 25, 1997 | K971946 | NPB-190 PULSE OXIMETER (NPB-190) Nellcor Puritan Bennett, Inc. | DQA |
| Jun 18, 1997 | K964019 | MORPHEE PLUS ALPHA Nellcor Puritan Bennett, Inc. | BZD |
| Feb 14, 1997 | K964543 | INFRASONICS ADULT VENTILATOR TRENDING OPTION Nellcor Puritan Bennett, Inc. | CBK |
| Feb 4, 1997 | K964494 | SLEEPWIZARD Nellcor Puritan Bennett, Inc. | MNR |
| Jan 24, 1997 | K964516 | TAP Nellcor Puritan Bennett, Inc. | LRK |
| Dec 13, 1996 | K963707 | NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) Nellcor Puritan Bennett, Inc. | DQA |
| Nov 26, 1996 | K963400 | NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER Nellcor Puritan Bennett, Inc. | DPS |
| Sep 10, 1996 | K962516 | TAP ANTI-SNORING DEVICE Nellcor Puritan Bennett, Inc. | LRK |
| Aug 1, 1996 | K961450 | SCORE SOFTWARE Nellcor Puritan Bennett, Inc. | DQA |
| Jul 2, 1996 | K955642 | NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER Nellcor Puritan Bennett, Inc. | DPS |
| Apr 26, 1996 | K960468 | DMR/CO2 COMBO KTI Nellcor Puritan Bennett, Inc. | BTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2007 | Nellcor Puritan Bennett Puritan Bennett 840 Ventilator System, Catalogue Numbers:
4-84O12OXXXX-XX, 4-840220XXXX-XX, 4-NPB84O-XX, DL4-NPB84O-XX, DS4-NPB840-XX & 4-070550-SP
(Note: the Xs indicate any combination of alpha cha Terminated |
CBK | K970460 |
| Aug 24, 2006 | Nellcor Puritan Bennett Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20 Terminated |
BSR | None listed |
| Apr 22, 2005 | Nellcor Puritan Bennett Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube,
Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed;
358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 3 Terminated |
JDH | K030787 |
| Mar 30, 2005 | Nellcor Puritan Bennett Nellcor brand Pulse Oximeter, model N-395,
Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A. Terminated |
DQA | K993637 |
| Mar 30, 2005 | Nellcor Puritan Bennett Nellcor brand OxiMax Pulse Oximeter, model number N-595
Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A. Terminated |
DQA | K012891 |
| Mar 30, 2005 | Nellcor Puritan Bennett Nellcor Puritan Bennett brand Pulse Oximeter, Model NPB295,
Made in Ireland; Distributed by Nellcor Puritan Bennett, Inc. Pleasanton, CA 94588 U.S.A. Terminated |
DQA | K973147 |
| Mar 30, 2005 | Nellcor Puritan Bennett Nellcor brand Pulse Oximeter, Model NPB290, MALLINCKRODT, Made in Ireland, Oxismart,
Made in Ireland; Distributed by Nellcor Puritan Bennett, Inc. Pleasanton, CA 94588 U.S.A. Terminated |
DQA | K972837 |
| Jan 28, 2005 | Nellcor Puritan Bennett Inc Model 740 and 760 series Ventilators. Terminated |
CBK | K964540 K984379 |
| Jan 28, 2005 | Nellcor Puritan Bennett Inc Internal Battery for Puritan Bennett 700 Series Ventilator. Terminated |
CBK | K964540 K984379 |
| Sep 2, 2004 | Nellcor Puritan Bennett The probes involved have been part of the Nellcor CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each pr Terminated |
CCK | K010795 |
| Aug 7, 2004 | Nellcor Puritan Bennett Shiley TracheoSoft XLT Extended Length Tracheostomy tube;
Model Numbers:
72110-050, size 5, Proximal Extension, Uncuffed;
72110-060, size 6, Proximal Extension, Uncuffed;
72110-070, size 7, Proximal Terminated |
--- | K003315 |