ORCA (tm) - Operational Rescue Containment Apparatus
FDA 510(k) clearance K163223 · decided 2017-11-02
Clearance details
- K-number
- K163223
- Device name
- ORCA (tm) - Operational Rescue Containment Apparatus
- Applicant
- Isovac Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-11-16
- Decision date
- 2017-11-02
- Days to decision
- 351 days
- Clearance type
- Traditional
- Product code
- LGM
- Device class
- 2
- Regulation number
- 880.5450
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Romeoville, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Carecube Negative Pressure Isolation Chamber (K231256) | Carecubes, Inc. | 2024-01-03 |
| PATIENT ISOLATION UNIT, MODEL G019-1000 (K080117) | Gentex Corporation | 2009-01-30 |
| FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS (K022260) | Isolation Systems, Inc. | 2002-08-29 |
| MTB 1043 TREATMENT BOOTH (K944133) | Mark Solutions, Inc. | 1995-09-07 |
| MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM (K912444) | Radiometer America, Inc. | 1992-02-18 |
| MODEL 7-AT TREATMENT CHAMBER (K896721) | J. H. Emerson Co. | 1990-01-22 |
| SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE (K884295) | Saybrex Intl., Inc. | 1988-11-08 |
| INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE (K874306) | Busse Hospital Disposables, Inc. | 1988-03-22 |
| ANAGO ISOLATION MASK (#80-950) (K864116) | Anago, Inc. | 1986-11-25 |
| ISOLATION MASK I.C.S. (K831062) | American Threshold Industries, Inc. | 1983-04-13 |
| STRETCHER TRANSIT ISOLATER #122 (K790657) | Vickers America Medical Corp. | 1979-07-03 |
Recalls involving this device
No recalls on record reference this clearance.