Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Narco Air-Shields — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
77 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K820114 | SYSTEM V.HEART RATE/RESPIR. RATE MONIT. | Narco Air-Shields | 1982-02-12 | 28 | 0 |
| K810953 | MODEL 533 PHOTOTHERAPY UNIT | Narco Air-Shields | 1981-04-23 | 16 | 0 |
| K810474 | PROBE COVER | Narco Air-Shields | 1981-03-31 | 36 | 0 |
| K802800 | NARCO AIR-SHEILDS SYS. 100 MONITOR SYS | Narco Air-Shields | 1980-11-24 | 18 | 0 |
| K802126 | ISOLETTE INCUBATOR C-100 | Narco Air-Shields | 1980-09-26 | 22 | 0 |
| K792592 | AMBU UNIVERSAL SUCTION PUMP | Narco Air-Shields | 1980-01-11 | 25 | 0 |
| K792499 | AMBU PAEDI ANAESTHESIA SYSTEM | Narco Air-Shields | 1979-12-19 | 15 | 0 |
| K792118 | AIR-SHIELDS RESUSCITATORS | Narco Air-Shields | 1979-11-13 | 18 | 0 |
| K792117 | AIR-SHIELDS HEART RATE MONITOR | Narco Air-Shields | 1979-11-13 | 18 | 0 |
| K790552 | AS7 & AS8 MONITORS | Narco Air-Shields | 1979-05-01 | 42 | 0 |
| K790551 | TRANSPORT INCUBATOR | Narco Air-Shields | 1979-04-24 | 35 | 0 |
| K790733 | VENTIMETER VENTILATOR | Narco Air-Shields | 1979-04-19 | 3 | 0 |
| K790732 | VENTIMETER CONTROLLER | Narco Air-Shields | 1979-04-19 | 3 | 0 |
| K790035 | AMBU SUCTION BOOSTER | Narco Air-Shields | 1979-03-23 | 77 | 0 |
| K790137 | INFANT CARE SYSTEM | Narco Air-Shields | 1979-03-06 | 43 | 0 |
| K790036 | DIGITAL BPM | Narco Air-Shields | 1979-03-02 | 53 | 0 |
| K790037 | SONO TRAK T.M. | Narco Air-Shields | 1979-01-26 | 18 | 0 |
| K782152 | VALVE, AMBU PEEP | Narco Air-Shields | 1978-12-26 | 0 | 1 |
| K780458 | TRANSCUTANEOUS OXYGEN PERFUSION MONITOR | Narco Air-Shields | 1978-10-10 | 201 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda