Lukens Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Lukens Corp.” (first 1977, latest 1988), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 51 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 2 | 2 |
| GES | Blade, Scalpel | 2 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| FRG | Wrap, Sterilization | 1 | 1 |
| IKK | System, Isokinetic Testing And Evaluation | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| KDC | Instrument, Surgical, Disposable | 1 | 1 |
| MTJ | Wax, Bone | 1 | 1 |
Review panels
- General and Plastic Surgery (5)
- General Hospital (3)
- Clinical Chemistry (1)
- Orthopedic (1)
- Physical Medicine (1)
Most recent Lukens Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880230 | SIXALYZER | IKK | 1988-03-16 | 56 |
| K800102 | STANFORD STERILE LAP SPONGES | GDY | 1980-01-28 | 12 |
| K792471 | STANFORD STERILE LAP SPONGES | GDY | 1979-12-20 | 17 |
| K791495 | LUKENS BONE WAX (GAMMA RADIATION) | MTJ | 1979-09-24 | 52 |
| K770797 | TRAY, CATHETERIZATION W/FOLEY, STERILE | FRG | 1977-07-11 | 70 |
| K770795 | SHAVE PREP SET | JJX | 1977-07-11 | 70 |
| K770799 | TRAY, IRRIGATION, STERILE, BASIC | KKX | 1977-06-22 | 51 |
| K770796 | SKIN SCRUB PREP SET | KKX | 1977-06-22 | 51 |
| K770800 | HANDLES, BLADE, SURGICAL | GES | 1977-05-06 | 4 |
| K770798 | BLADES, SURGICAL, STERILE | GES | 1977-05-06 | 4 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lukens 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.
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.
- Lukens Medical Corp. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lukens Corp.?
FDA lists 11 510(k) clearances under the applicant name “Lukens Corp.” (first 1977, latest 1988), across 8 product codes in 5 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 Lukens Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lukens Corp. is 51 days.
Which FDA product codes appear under Lukens Corp.?
The most frequent FDA product codes under this applicant name are GDY (Gauze/Sponge, Internal, X-Ray Detectable, 2); GES (Blade, Scalpel, 2); KKX (Drape, Surgical, Antimicrobial, 2).
Next steps
- See all 11 Lukens Corp. clearances with predicates and recalls
- Run predicate analysis for product code GDY, Lukens 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.