BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)
FDA 510(k) clearance K930252 · decided 1993-02-09
Clearance details
- K-number
- K930252
- Device name
- BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)
- Applicant
- Bird Life Design
- Decision
- Substantially Equivalent
- Date received
- 1993-01-08
- Decision date
- 1993-02-09
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- CAI
- Device class
- 1
- Regulation number
- 868.5240
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Carrollton, TX, US
- Third-party review
- No
- Expedited review
- No
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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
| Record | Firm | Date |
|---|---|---|
| Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure moni recall (Z-0033-04) | VIASYS Med Systems | 2003-10-15 |
| Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure moni recall (Z-0034-04) | VIASYS Med Systems | 2003-10-15 |
| Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure moni recall (Z-0035-04) | VIASYS Med Systems | 2003-10-15 |
| Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxy recall (Z-0036-04) | VIASYS Med Systems | 2003-10-15 |
| Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Co recall (Z-0037-04) | VIASYS Med Systems | 2003-10-15 |
| Sideport Kit w/Oxygen Line, consisting of an adjustable sideport valve, an O2 port elbow a recall (Z-0038-04) | VIASYS Med Systems | 2003-10-15 |