Alba-Waldensian, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Alba-Waldensian, Inc.” (first 1977, latest 2002), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | 1 | 1 |
| FMP | Protector, Skin Pressure | 1 | 1 |
| FQM | Bandage, Elastic | 1 | 1 |
| ILG | Stocking, Elastic | 1 | 1 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
Review panels
Most recent Alba-Waldensian, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020592 | ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 | DWL | 2002-04-03 | 40 |
| K961405 | ALBA HEALTH PAS WRAP SYSTEM | JOW | 1996-12-26 | 259 |
| K852091 | ALBA DRY BURN PAD | NAD | 1985-06-13 | 31 |
| K792357 | STERILE IMPERVIOUS ORTHOPEDIC STOCKIN | KKX | 1979-12-18 | 27 |
| K781964 | COMPRESSION DEVICES, LIMB | IRP | 1978-12-12 | 22 |
| K780570 | TUBULAR DRESSING RETAINER | FQM | 1978-04-19 | 9 |
| K780547 | STERILE ORTHOPEDIC STOCKINETTE | ILG | 1978-04-10 | 5 |
| K771913 | HEEL/ELBOW PROTECTOR | FMP | 1977-11-15 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Alba-Waldensian, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Alba-Waldensian, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Alba-Waldensian, Inc.” (first 1977, latest 2002), across 8 product codes in 4 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 Alba-Waldensian, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alba-Waldensian, Inc. is 29 days.
Which FDA product codes appear under Alba-Waldensian, Inc.?
The most frequent FDA product codes under this applicant name are DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs), 1); FMP (Protector, Skin Pressure, 1); FQM (Bandage, Elastic, 1).
Next steps
- See all 8 Alba-Waldensian, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWL, Alba-Waldensian, 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.