Flowmeter, Tube, Thorpe, Back-Pressure Compensated
FDA product code CAX · Class I (low risk) · 21 CFR 868.2340 · Anesthesiology
24510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Timeter Instrument Corp. 6
- Precision Medical, Inc. 3
- Precision Metering, Inc. 2
- Ohio Medical Products 1
- Harris-Lake, Inc. 1
- Chemetron Medical Products, Inc. 1
- Union Carbide Corp. 1
- Harris Calorific 1
- Design & Manufacturing Consultants 1
- Bar-Dix, Inc. 1
- Airco, Inc. 1
- The Timeter Group 1
- Puritan Bennett Corp. 1
- Key Instruments 1
- Ohmeda Medical 1
- Porter Instrument Co., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923781 | MXR-2000 FlowmeterCAX · Traditional | Porter Instrument Co., Inc. | 06/10/1993SE |
| K910316 | Ohmeda - Low Flow FlowmeterCAX · Traditional | Ohmeda Medical | 04/12/1991SE |
| K884973 | FR6000 FlowmeterCAX · Traditional | Key Instruments | 01/17/1989SE |
| K872718 | Series D FlowmeterCAX · Traditional | Puritan Bennett Corp. | 08/05/1987SE |
| K871452 | Classic (TM) 200 Oxygen FlowmeterCAX · Traditional | The Timeter Group | 06/22/1987SE |
| K862797 | Airco 2000 Series FlowmetersCAX · Traditional | Airco, Inc. | 08/08/1986SE |
| K854067 | Select FlowmeterCAX · Traditional | Precision Medical, Inc. | 10/29/1985SE |
| K851288 | Oxygen Delivery Measuring DeviceCAX · Traditional | Bar-Dix, Inc. | 09/03/1985SE |
| K850559 | Pressure Relief AdaptorCAX · Traditional | Precision Medical, Inc. | 04/25/1985SE |
| K850560 | Flowmeter, Backpressure Compensated, Thorpe TubeCAX · Traditional | Precision Medical, Inc. | 04/17/1985SE |
| K834260 | RECON-2 Flow ControllerCAX · Traditional | Precision Metering, Inc. | 01/10/1984SE |
| K812419 | Preset FlowmeterCAX · Traditional | Timeter Instrument Corp. | 09/21/1981SE |
| K812183 | Timeter-Produced Puritan Bennett Air AdpCAX · Traditional | Timeter Instrument Corp. | 08/18/1981SE |
| K812128 | Recon 1CAX · Traditional | Precision Metering, Inc. | 08/18/1981SE |
| K802659 | Respiratory Therapy FlowmeterCAX · Traditional | Design & Manufacturing Consultants | 11/12/1980SE |
| K802311 | MO8 Oxygen FlowmeterCAX · Traditional | Timeter Instrument Corp. | 10/23/1980SE |
| K791900 | M015 Oxygen & MA15 AirCAX · Traditional | Timeter Instrument Corp. | 10/11/1979SE |
| K791648 | Model 54 Flowmeter Back-Pressure TubeCAX · Traditional | Harris Calorific | 09/17/1979SE |
| K791220 | Flowmeter, Back Pressure Compensated,CAX · Traditional | Timeter Instrument Corp. | 08/03/1979SE |
| K791017 | Flow LimiterCAX · Traditional | Timeter Instrument Corp. | 07/03/1979SE |
| K791069 | Linde Oxygen Therapy Flowmeters, L33-L34CAX · Traditional | Union Carbide Corp. | 06/27/1979SE |
| K781541 | FlometerCAX · Traditional | Chemetron Medical Products, Inc. | 09/26/1978SE |
| K760314 | Flowmeter, OxygenCAX · Traditional | Harris-Lake, Inc. | 08/04/1976SE |
| K760102 | Flowmeter, P.C., Redesigned VersionCAX · Traditional | Ohio Medical Products | 07/16/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0228-2009 | Bag Tee Assembly Model P1407A . An accessory to the dental flowmeter which has a…inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas | Porter Instrument Co Inc | 08/26/2008Terminated |