Narco Air-Shields: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Narco Air-Shields” (first 1978, latest 1982), across 16 product codes in 5 review panels. Median 510(k) review time under this name: 22 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 | 3 |
| CBK | Ventilator, Continuous, Facility Use | 2 | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| CBC | Bottle, Collection And Trap, Breathing System (Uncalibrated) | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| DXO | Transducer, Pressure, Catheter Tip | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
Plus 6 more product codes.
Review panels
- Anesthesiology (6)
- General Hospital (6)
- Cardiovascular (5)
- Radiology (1)
- General and Plastic Surgery (1)
Most recent Narco Air-Shields 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K820114 | SYSTEM V.HEART RATE/RESPIR. RATE MONIT. | DRT | 1982-02-12 | 28 |
| K810953 | MODEL 533 PHOTOTHERAPY UNIT | LBI | 1981-04-23 | 16 |
| K810474 | PROBE COVER | FLL | 1981-03-31 | 36 |
| K802800 | NARCO AIR-SHEILDS SYS. 100 MONITOR SYS | DXG | 1980-11-24 | 18 |
| K802126 | ISOLETTE INCUBATOR C-100 | FMZ | 1980-09-26 | 22 |
| K792592 | AMBU UNIVERSAL SUCTION PUMP | JCX | 1980-01-11 | 25 |
| K792499 | AMBU PAEDI ANAESTHESIA SYSTEM | CAI | 1979-12-19 | 15 |
| K792118 | AIR-SHIELDS RESUSCITATORS | BTM | 1979-11-13 | 18 |
| K792117 | AIR-SHIELDS HEART RATE MONITOR | DRT | 1979-11-13 | 18 |
| K790552 | AS7 & AS8 MONITORS | DRT | 1979-05-01 | 42 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Narco Air-Shields.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Narco Scientific (30 510(k)s)
- Narco Bio-Systems (9 510(k)s)
- Narco Mckesson Co. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Narco Air-Shields?
FDA lists 19 510(k) clearances under the applicant name “Narco Air-Shields” (first 1978, latest 1982), across 16 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Narco Air-Shields?
The median time from FDA receipt to decision across 510(k)s cleared under the name Narco Air-Shields is 22 days.
Which FDA product codes appear under Narco Air-Shields?
The most frequent FDA product codes under this applicant name are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 3); CBK (Ventilator, Continuous, Facility Use, 2); BTM (Ventilator, Emergency, Manual (Resuscitator), 1).
Next steps
- See all 19 Narco Air-Shields clearances with predicates and recalls
- Run predicate analysis for product code DRT, Narco Air-Shields's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.