FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3
K Number: K024270
·
Decision Jun 24, 2003
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
18
Review Days
183
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3
- K Number
- K024270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intersurgical, Inc.
- Date Received
- December 23, 2002
- Decision Date
- June 24, 2003
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAH), ordered by most recent decision date.
Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
FDA 510(k)
FDA Class 2
·Anesthesiology
Ambu® Virobac II® Exhalation Filter
FDA 510(k)
FDA Class 2
·Anesthesiology
Besmed Bacterial Filter and HMEF
FDA 510(k)
FDA Class 2
·Anesthesiology
Breathing circuit bacterial/viral filter
FDA 510(k)
FDA Class 2
·Anesthesiology
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
FDA 510(k)
FDA Class 2
·Anesthesiology
TNI Clear-Guard 3 angled breathing filter (1545020)
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Intersurgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122077 | MANOMETER | Jan 10, 2013 | Substantially Equivalent |
| K122075 | DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER | Dec 20, 2012 | Substantially Equivalent |
| K121026 | FLO-GUARD BREATHING FILTER | Nov 2, 2012 | Substantially Equivalent |
| K092451 | INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER | Oct 29, 2010 | Substantially Equivalent |
| K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 | May 18, 2010 | Substantially Equivalent |
| K092409 | HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER | Mar 10, 2010 | Substantially Equivalent |
| K032322 | CLEAR-THERM MICRO HME, MODEL 1441 | May 13, 2004 | Substantially Equivalent |
| K990949 | CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT | Jun 15, 1999 | Substantially Equivalent |
| K983610 | CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18 | Apr 30, 1999 | Substantially Equivalent |
| K984481 | EXHALATION VALVE | Jan 29, 1999 | Substantially Equivalent |