RESUSIKIT
FDA 510(k) clearance K861482 · decided 1986-06-17
Clearance details
- K-number
- K861482
- Device name
- RESUSIKIT
- Applicant
- Begley Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-22
- Decision date
- 1986-06-17
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- CAE
- Device class
- 1
- Regulation number
- 868.5110
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Pendleton, IN, 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 |
|---|---|---|
| LMA FAMILY OF AIRWAYS (K130304) | The Laryngeal Mask Co., Ltd. | 2014-05-30 |
| KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 (K033189) | King Systems Corp. | 2004-05-04 |
| KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 (K033186) | King Systems Corp. | 2004-04-14 |
| KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 (K021634) | King Systems Corp. | 2003-01-09 |
| CUFFED OROPHARYNGEAL AIRWAY (COPA) (K955721) | Mallinckrodt Medical | 1997-03-28 |
| RUSCH OPTOSAFE (K960240) | Rusch Intl. | 1996-04-19 |
| KEISEI (K950613) | Keisei (Usa) Co., Ltd. | 1996-02-14 |
| GUEDEL AIRWAY (K953400) | Mallinckrodt Medical | 1995-10-24 |
| STB GUEDEL AIRWAY (K933760) | Save-T-Breath Distributors C.C. | 1994-03-23 |
| BERMAN AIRWAY (K936134) | Smiths Industries Medical Systems, Inc. | 1994-01-28 |
| GUEDEL AIRWAY (K922748) | Oem Medical Div. | 1992-07-10 |
| BERMAN INTUBATING/PHARYNGEAL AIRWAY (K913680) | Chain Plastics Operations, Inc. | 1991-10-10 |
Recalls involving this device
No recalls on record reference this clearance.