Preemicare Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Preemicare Corp.” (first 1988, latest 1991), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 163 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 2 | 2 |
| FMZ | Incubator, Neonatal | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
| FPL | Incubator, Neonatal Transport | 1 | 1 |
| LBI | Unit, Neonatal Phototherapy | 1 | 1 |
Review panels
- General Hospital (5)
- Anesthesiology (4)
Most recent Preemicare Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911450 | INFANT VENTILATOR | CBK | 1991-06-18 | 85 |
| K896375 | PREEMICARE NEBUTECH NEBULIZER SYSTEM | CAF | 1990-10-29 | 357 |
| K900735 | MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR | FMZ | 1990-05-02 | 75 |
| K893622 | PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL. | CBK | 1990-01-03 | 237 |
| K893624 | PREEMICARE MODEL 2500 TRANSPORT WARMER | FPL | 1989-09-27 | 139 |
| K891674 | NEONATAL ENVIRONMENTAL MONITOR, MODEL 275 | CCL | 1989-08-31 | 163 |
| K885350 | PREEMICARE SERIES 2000 INFANT WARMER | FMT | 1989-08-07 | 222 |
| K884133 | PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP | LBI | 1989-03-08 | 159 |
| K881476 | PREEMICARE MODEL D1-X1, SERIES 3000 | FMZ | 1988-12-08 | 245 |
Recalls
openFDA lists no recalls under a recalling firm named Preemicare Corp..
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 Preemicare Corp. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Preemicare Corp.?
FDA lists 9 510(k) clearances under the applicant name “Preemicare Corp.” (first 1988, latest 1991), across 7 product codes in 2 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 Preemicare Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Preemicare Corp. is 163 days.
Which FDA product codes appear under Preemicare Corp.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 2); FMZ (Incubator, Neonatal, 2); CAF (Nebulizer (Direct Patient Interface), 1).
Next steps
- See all 9 Preemicare Corp. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Preemicare Corp.'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.