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Panels › Anesthesiology › Product code BZO · Class 1

Set, Tubing And Support, Ventilator (W Harness)

Regulation 868.5975

0510(k)s in 12 months (88 all time)
2recalls in 12 months (23 all time)
4recalls that name a 510(k)
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Top companies in BZO

DateFirm and productCodeLinked 510(k)
Aug 21, 2026Medline Industries, LP
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONAT
Open, Classified
BZOK903083
Jun 30, 2026Hamilton Medical AG
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Open, Classified
BZONone listed
Oct 14, 2025Percussionaire Corporation
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Open, Classified
BZONone listed
Jul 30, 2025Hamilton Medical AG
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Open, Classified
BZONone listed
Apr 3, 2025Draeger, Inc.
Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an
Open, Classified
BZONone listed
Sep 27, 2024Percussionaire Corporation
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Open, Classified
BZONone listed
Sep 27, 2024Percussionaire Corporation
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Open, Classified
BZONone listed
Sep 9, 2023Mallinckrodt Manufacturing LLC
Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Open, Classified
BZONone listed
May 17, 2023Draeger Medical, Inc.
Ventstar Coax 230, MP03376
Terminated
BZONone listed
May 17, 2023Draeger Medical, Inc.
ID Coax 180, MP03375
Terminated
BZONone listed
May 17, 2023Draeger Medical, Inc.
Ventstar Coax 180, MP03374
Terminated
BZONone listed
May 17, 2023Draeger Medical, Inc.
Ventstar Coax, MP03373
Terminated
BZONone listed
May 17, 2023Draeger Medical, Inc.
VentStar Coax (P) 150, MP00379
Terminated
BZONone listed
May 17, 2023Draeger Medical, Inc.
ID Circuit Basic (P) 180, MP01340
Terminated
BZONone listed
Apr 11, 2022TELEFLEX MEDICAL INC
(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile;
Open, Classified
BZONone listed
Jul 2, 2015Hamilton Medical, Inc.
Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a d
Terminated
BZOK945740
Jul 2, 2015Hamilton Medical, Inc.
Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a
Terminated
BZOK945740
Jul 2, 2015Hamilton Medical, Inc.
Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a d
Terminated
BZOK945740
May 20, 2014Fisher & Paykel Healthcare, Ltd.
Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-1
Terminated
BZONone listed
Apr 10, 2014Draeger Medical, Inc.
Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia s
Terminated
BZONone listed
Jan 3, 2013Fisher & Paykel Healthcare, Ltd.
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Terminated
BZONone listed
Jul 22, 2004Medex Inc
Ventilator Circuit with ''Y'' & elbow with 2 Water Traps, for use with/compatible with Bennett 7200; product reorder 6072WT; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products,
Terminated
BZONone listed
Jul 22, 2004Medex Inc
IPI Ventilator Circuit with 2 Water Traps, product reorder no. 6066; SIngle Patient Use Only; Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641
Terminated
BZONone listed

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