Air-Shields Vickers, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Air-Shields Vickers, Inc.” (first 1988, latest 1995), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 126 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 | 6 | 6 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 1 | 1 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 1 | 1 |
| LBI | Unit, Neonatal Phototherapy | 1 | 1 |
Review panels
Most recent Air-Shields Vickers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924679 | OXYCARE(TM) OXYGEN CONTROLLER/MONITOR | KLK | 1995-02-21 | 888 |
| K924297 | DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER | FMZ | 1993-03-18 | 204 |
| K912908 | AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM | LBI | 1991-12-13 | 164 |
| K912909 | SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM | FMZ | 1991-11-05 | 126 |
| K912910 | C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM | FMZ | 1991-10-30 | 120 |
| K904691 | AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST | HFM | 1991-02-19 | 126 |
| K903378 | MODEL C286 ISOLETTE INFANT INCUBATOR | FMZ | 1990-10-15 | 77 |
| K895782 | NEONATAL INCUBATOR (ACCESSORY) | FMZ | 1989-12-07 | 71 |
| K884086 | C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR | FMZ | 1988-11-14 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Air-Shields Vickers, 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.
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, Inc. (33 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Air-Shields Vickers, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Air-Shields Vickers, Inc.” (first 1988, latest 1995), across 4 product codes in 3 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 Vickers, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Air-Shields Vickers, Inc. is 126 days.
Which FDA product codes appear under Air-Shields Vickers, Inc.?
The most frequent FDA product codes under this applicant name are FMZ (Incubator, Neonatal, 6); HFM (Monitor, Uterine Contraction, External (For Use In Clinic), 1); KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia, 1).
Next steps
- See all 9 Air-Shields Vickers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMZ, Air-Shields Vickers, 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.