ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAP
FDA 510(k) clearance K893919 · decided 1989-09-15
Clearance details
- K-number
- K893919
- Device name
- ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAP
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1989-05-30
- Decision date
- 1989-09-15
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- CAI
- Device class
- 1
- Regulation number
- 868.5240
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Valencia, CA, 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 |
|---|---|---|
| CONDENSATE COLLECTION KIT (K954480) | Nova-Ventrx | 1995-12-29 |
| UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (K953788) | Unicor, Inc. | 1995-09-19 |
| UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (K953787) | Unicor, Inc. | 1995-09-19 |
| PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (K952014) | Prima, Inc. | 1995-05-22 |
| PRIMA ADULT GAS SAMPLING CIRCUITS (K952019) | Prima, Inc. | 1995-05-22 |
| PRIMA COAXIAL CIRCUITS (K952018) | Prima, Inc. | 1995-05-22 |
| PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (K952016) | Prima, Inc. | 1995-05-22 |
| PRIMA MAPLESON D CIRCUIT (K952017) | Prima, Inc. | 1995-05-22 |
| PRIMA PEDIATRIC ANESTHESIA CIRCUITS (K952020) | Prima, Inc. | 1995-05-22 |
| PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (K952009) | Prima, Inc. | 1995-05-19 |
| SPIRO-FLEX (K945565) | Inhalation Plastics | 1995-01-13 |
| NEONATAL BREATHING CIRCUIT MODIFICATION (K932288) | Simplex Medical Systems, Inc. | 1994-12-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |