Alba Health Care: FDA clearances and approvals
Alba Health Care has 8 FDA 510(k) clearances (first 1981, latest 1987), across 7 product codes in 3 review panels. Median 510(k) review time: 46 days.
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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FOK | Pad, Neonatal Eye | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| FYB | Gown, Patient | 1 | 1 |
| LGF | Component, Cast | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Alba Health Care 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864689 | ALBA HEALTH CARE IODOFORM PACKING STRIP | — | 1987-01-20 | 49 |
| K861154 | ALBA HEALTH CARE PLAIN PACKING STRIP | EFQ | 1986-04-15 | 18 |
| K851918 | INFANT PHOTOTHERAPY MASK | FOK | 1985-06-07 | 36 |
| K850904 | ALBA DRY BURN DRESSING | NAD | 1985-04-17 | 43 |
| K850881 | ALBA DRY BURN PAD | — | 1985-04-17 | 44 |
| K850241 | ALBA HEALTH CARE NON-ADHERING DRESSING | FRO | 1985-03-12 | 49 |
| K812904 | STERILE ORTHOPEDIC STOCKINETTE | LGF | 1982-01-18 | 91 |
| K803171 | PROCEDURE & RECOVERY PATIENT SUIT | FYB | 1981-03-04 | 79 |
Recalls
openFDA lists no recalls under a recalling firm named Alba Health Care.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Alba Health Care have?
Alba Health Care has 8 FDA 510(k) clearances (first 1981, latest 1987), across 7 product codes in 3 review panels.
How long does FDA take to clear Alba Health Care's 510(k)s?
The median time from FDA receipt to decision across Alba Health Care's cleared 510(k)s is 46 days.
What devices does Alba Health Care make?
Its most frequent FDA product codes are EFQ (Gauze/Sponge, Internal, 1); FOK (Pad, Neonatal Eye, 1); FRO (Dressing, Wound, Drug, 1).
Has Alba Health Care had device recalls?
openFDA lists no recalls under a recalling firm name matching Alba Health Care. Related entities may recall under other names.
Next steps
- See all 8 Alba Health Care clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Alba Health Care's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.