Breathing Bags

FDA 510(k) K932581 · Med-Plastics Intl., Inc.

Substantially Equivalent

510(k) numberK932581

Submission

Device name
Breathing Bags
Applicant
Med-Plastics Intl., Inc.
Indianapolis, IN, US
Received
May 27, 1993
Decision date
July 16, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BTC – Bag, Reservoir
Device class
Class I (low risk)
Regulation
21 CFR 868.5320
Specialty
Anesthesiology

Other 510(k)s with product code BTC

510(k)DeviceApplicantDecision
K181424PeDIABTC · Traditional Pedia, LLC09/25/2018SE
K940220Rebreather BagsBTC · Traditional Zefon Medical Products05/27/1994SE
K932584Breathing BagsBTC · Traditional Merit Medical Systems, Inc.07/16/1993SE
K932496Precision Med Products, Ltd. Breathing BagsBTC · Traditional Precision Med Products, Ltd.07/16/1993SE
K932191Breathing BagsBTC · Traditional Life Shield Healthcare Products, Inc.07/02/1993SE
K894906Anesthesia Breathing Bags Sizes 1/2, 1,2,3 LiterBTC · Traditional Med-Tek Corp.09/18/1989SE
K880680King Systems, Breathing BagBTC · Traditional King Systems Corp.03/03/1988SE
K864822Varidyne 550, Models 12E,12M,24E & 24M Suction SysBTC · Traditional Surgidyne, Inc.01/15/1987SE
K841412Rolled Neck W/TapBTC · Traditional Warne Surgical Products, Ltd.04/18/1984SE
K841411Rolled Neck W/PlugBTC · Traditional Warne Surgical Products, Ltd.04/18/1984SE

More from Warne Surgical Products, Ltd.

510(k)DeviceDecision
K946209Dispodable Heat & Moisture Exchanger and Filter/HmeBYD · Traditional 06/08/1995SE
K942572Volume VentilatorBZO · Traditional 06/10/1994SE
K942571Hyper-Inflation BagNHK · Traditional 06/10/1994SE
K942570Mapleson D CircuitCAI · Traditional 06/10/1994SE
K942569Ventilator HoseBZO · Traditional 06/10/1994SE
K942568Adult Anesthesia Breathing CircuitCAI · Traditional 06/10/1994SE
K942567Mass Spectrometry Monitoring Lines and ConnectorsCCK · Traditional 06/10/1994SE
K932578Adult Gas Sampling CircuitsCAI · Traditional 07/22/1993SE
K932577Pediatric Gas SamplingCAI · Traditional 07/22/1993SE
K932576Pediatric Temperature Monitoring CircuitsCAI · Traditional 07/22/1993SE

Questions and answers

When was Breathing Bags cleared by the FDA?

Breathing Bags (K932581) received a 510(k) decision of Substantially Equivalent on July 16, 1993, 50 days after the submission was received.

What is the product code of K932581?

The FDA product code is BTC – Bag, Reservoir, a Class I (low risk) device regulated under 21 CFR 868.5320.