Resp-Bac Bacteria Filter
510(k) K851070
Resp-Bac Bacteria Filter is a medical device (FDA Class II; FDA product code CAH, Filter, Bacterial, Breathing-Circuit) made by Medicomp, Inc., cleared under FDA 510(k) K851070 on 14 Jun 1985, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK851070 | Date14 Jun 1985 | StatusActive |
Official records
- FDA 510(k) database K851070
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CAH
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5260
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K851070
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Adult Bacterial/Viral Filter MC-500 | MC-500 / MC-500 | 00858409005009 | No longer on the market | |
| Adult Bacterial/Viral Filter with C02 Port MC-555X | MC-555X / MC-555X | 00858409005368 | No longer on the market | |
| BVF22 Bacteria Filter | BVF22 | 00819989014904 | On the market | |
| Infant Bacterial/Viral Filter MC-125 | MC-125 / MC-125 | 00858409005016 | No longer on the market | |
| Nebulizer Bacteria Filter MC-350 | MC-350 / MC-350 | 00858409005023 | No longer on the market | |
| Spirometer Bacterial/Viral Filter MC-850 | MC-850 / MC-850 | 00858409005030 | No longer on the market |
Similar devices
Other devices filed under FDA product code CAH (Filter, Bacterial, Breathing-Circuit).
- ALL FLOW PULMONARY FUNCTION FILTER by ALLIANCE TECH MEDICAL, INC.
- VentiShield Adult Bacterial Viral Filter with Luer Port 038-41-365STRU by FLEXICARE MEDICAL LIMITED
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- ENGSTROM HMEF 1000 by Datex-Engstrom, Inc.
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- CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT by Intersurgical, Inc.
- ThermoShield Adult Bacterial Viral HMEF with Luer Port + Standard Catheter Mount 038-41-355/301U by FLEXICARE MEDICAL LIMITED
- POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER by Porous Media Corp.
- DATEX-OHMEDA HMEF MINI by Datex-Ohmeda Inc.
- MODIFIED ENTRAPPING FILTER by Cadema Medical Products, Inc.