The Owenby Co.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “The Owenby Co.” (first 1976, latest 1980), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| FYF | Cap, Surgical | 3 | 3 |
| FQM | Bandage, Elastic | 2 | 2 |
| ILI | Sling, Arm | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FPY | Sheet, Burn | 1 | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| FXY | Hood, Surgical | 1 | 1 |
| IPM | Cover, Limb | 1 | 1 |
| IQK | Orthosis, Cervical | 1 | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 | 1 |
Review panels
Most recent The Owenby Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K801628 | RESTRAINT, PROTECTIVE | IQK | 1980-08-07 | 23 |
| K801627 | COVER, LIMB | IPM | 1980-07-28 | 13 |
| K801626 | ARM SLING | ILI | 1980-07-28 | 13 |
| K801532 | STOCKINETTE, STERILE TWO PLY W/PULL TABS | FQM | 1980-07-28 | 27 |
| K801531 | ARM SLING | ILI | 1980-07-21 | 20 |
| K790210 | STOCKINETTE, TUBULAR UNBLEACHED | FQM | 1979-02-27 | 28 |
| K780764 | NON-STERILE FOLDED GAUZE | NAB | 1978-06-06 | 33 |
| K780418 | BURN DRESSING PAD | FPY | 1978-04-10 | 27 |
| K770889 | BURN DRESSING KIT | EFQ | 1977-07-11 | 56 |
| K761071 | P.S.M. JUSTA KAP | FYF | 1976-12-30 | 44 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Owenby Co..
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 The Owenby Co.?
FDA lists 14 510(k) clearances under the applicant name “The Owenby Co.” (first 1976, latest 1980), across 10 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 The Owenby Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Owenby Co. is 28 days.
Which FDA product codes appear under The Owenby Co.?
The most frequent FDA product codes under this applicant name are FYF (Cap, Surgical, 3); FQM (Bandage, Elastic, 2); ILI (Sling, Arm, 2).
Next steps
- See all 14 The Owenby Co. clearances with predicates and recalls
- Run predicate analysis for product code FYF, The Owenby Co.'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.