RESUSCITATOR MODELS 10400/10500/10600/10700/10800
FDA 510(k) clearance K862192 · decided 1986-07-07
Clearance details
- K-number
- K862192
- Device name
- RESUSCITATOR MODELS 10400/10500/10600/10700/10800
- Applicant
- U.O. Equipment Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-06-09
- Decision date
- 1986-07-07
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- BTL
- Device class
- 2
- Regulation number
- 868.5925
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch U.O. Equipment Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (K242769) | Draegerwerk AG & CO Kgaa | 2025-04-04 |
| Oxymag - Transport and Emergency Ventilator (K221634) | Magnamed Tecnologia Medica S/A | 2023-05-24 |
| VORTRAN GO2VENT with PEEP Valve (K202219) | Vortran Medical Technology 1, Inc. | 2021-02-11 |
| MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (K193191) | Weinmann Emergency Medical Technology GmbH + Co. KG | 2020-11-20 |
| Puffin Lite Infant Resuscitation System (K182956) | International Biomedical | 2019-01-18 |
| SafeT T-Piece Resuscitator (K173373) | Ventlab, LLC | 2018-11-16 |
| MOVES SLC (K161420) | Thornhill Research, Inc. | 2017-06-06 |
| VORTRAN GO2VENT (K162968) | Vortran Medical Technology 1, Inc. | 2017-04-10 |
| O-TWO E700,O-TWO E600,O-TWO E500 (K141595) | O-Two Medical Technologies, Inc. | 2015-03-16 |
| T-PIECE RESUSCITATOR (K142096) | Mercury Medical | 2014-10-17 |
| MOVES SLC (K140049) | Thornhill Research, Inc. | 2014-05-29 |
| LIFEBORNE INFANT RESUSCITATOR (K140707) | International Biomedical | 2014-05-28 |
Recalls involving this device
No recalls on record reference this clearance.