Air-Shields, Inc.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Air-Shields, Inc.” (first 1976, latest 1998), across 19 product codes in 6 review panels. Median 510(k) review time under this name: 75 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 |
|---|---|---|---|
| FMZ | Incubator, Neonatal | 7 | 7 |
| FMT | Warmer, Infant Radiant | 5 | 5 |
| LBI | Unit, Neonatal Phototherapy | 3 | 3 |
| DSF | Recorder, Paper Chart | 2 | 2 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
Plus 9 more product codes.
Review panels
- General Hospital (19)
- Anesthesiology (5)
- Cardiovascular (4)
- Obstetrics and Gynecology (3)
- Clinical Chemistry (1)
- Radiology (1)
Most recent Air-Shields, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974248 | WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM | HGM | 1998-10-07 | 329 |
| K972309 | JM-102 JAUNDICE METER | MQM | 1998-09-22 | 459 |
| K971256 | DUO-LITE PHOTOTHERAPY SYSTEM | LBI | 1997-09-24 | 173 |
| K960980 | ISOLETTE INFANT INCUBATOR | FMZ | 1996-07-30 | 141 |
| K924709 | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE | KLK | 1996-01-17 | 1216 |
| K940951 | RW RESUCITAIRE INFANT RADIANT WARMER | FMT | 1995-05-03 | 427 |
| K940975 | C450/C400 INFANT INCUBATORS | FMZ | 1994-06-23 | 112 |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | FPL | 1994-06-10 | 95 |
| K924170 | ISOLETTE INCUBATOR HUMIDITY METER | FMZ | 1993-02-05 | 170 |
| K922150 | EXAMINATION LAMP | KZF | 1992-07-21 | 75 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Air-Shields, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Air-Shields, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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.
- Air-Shields Vickers, Inc. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Air-Shields, Inc.?
FDA lists 33 510(k) clearances under the applicant name “Air-Shields, Inc.” (first 1976, latest 1998), across 19 product codes in 6 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 Air-Shields, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Air-Shields, Inc. is 75 days.
Which FDA product codes appear under Air-Shields, Inc.?
The most frequent FDA product codes under this applicant name are FMZ (Incubator, Neonatal, 7); FMT (Warmer, Infant Radiant, 5); LBI (Unit, Neonatal Phototherapy, 3).
Next steps
- See all 33 Air-Shields, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMZ, Air-Shields, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.