Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lukens Corp. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
70 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880230 | SIXALYZER | Lukens Corp. | 1988-03-16 | 56 | 0 |
| K800102 | STANFORD STERILE LAP SPONGES | Lukens Corp. | 1980-01-28 | 12 | 0 |
| K792471 | STANFORD STERILE LAP SPONGES | Lukens Corp. | 1979-12-20 | 17 | 0 |
| K791495 | LUKENS BONE WAX (GAMMA RADIATION) | Lukens Corp. | 1979-09-24 | 52 | 0 |
| K770795 | SHAVE PREP SET | Lukens Corp. | 1977-07-11 | 70 | 0 |
| K770797 | TRAY, CATHETERIZATION W/FOLEY, STERILE | Lukens Corp. | 1977-07-11 | 70 | 0 |
| K770799 | TRAY, IRRIGATION, STERILE, BASIC | Lukens Corp. | 1977-06-22 | 51 | 0 |
| K770796 | SKIN SCRUB PREP SET | Lukens Corp. | 1977-06-22 | 51 | 0 |
| K770800 | HANDLES, BLADE, SURGICAL | Lukens Corp. | 1977-05-06 | 4 | 0 |
| K770794 | SUTURE REMOVAL SET, STERILE | Lukens Corp. | 1977-05-06 | 4 | 0 |
| K770798 | BLADES, SURGICAL, STERILE | Lukens Corp. | 1977-05-06 | 4 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda