Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acme United Corp. · Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
47 daysmedian FDA review time
165 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961323 | LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING | Acme United Corp. | 1996-06-19 | 75 | 0 |
| K961452 | LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING | Acme United Corp. | 1996-05-31 | 45 | 0 |
| K952565 | LYOFOAM EXTRA | Acme United Corp. | 1995-11-14 | 165 | 0 |
| K895764 | MODIFIED LYOFOAM WOUND DRESSINGS | Acme United Corp. | 1990-09-10 | 349 | 0 |
| K871740 | LYOSHEET SURGICAL SHEET FOR BURNS | Acme United Corp. | 1987-06-09 | 35 | 0 |
| K864084 | LYOFOAM C ODOR-ABSORBING DRESSING | Acme United Corp. | 1986-11-21 | 32 | 0 |
| K860085 | LYOFOAM WOUND DRESSINGS | Acme United Corp. | 1986-06-27 | 169 | 0 |
| K860818 | ONE TIME ENTERAL FEEDING BAG | Acme United Corp. | 1986-05-15 | 72 | 0 |
| K861015 | ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS | Acme United Corp. | 1986-04-22 | 35 | 0 |
| K842186 | ACU-DERM TRANSPARENT WOUND DRESSING | Acme United Corp. | 1984-08-24 | 84 | 0 |
| K842064 | ACU-DERM TRANSPARENT IV DRESSING | Acme United Corp. | 1984-08-15 | 86 | 0 |
| K841735 | ACU-DERM TRANSPARENT INCISE DRAPE | Acme United Corp. | 1984-08-02 | 98 | 0 |
| K833120 | ONE TIME COMPOUND BENZOIN TINCTURE- | Acme United Corp. | 1983-12-29 | 107 | 0 |
| K833141 | ONE TIME ACETONE/ALCOHOL;SWAB STICKS | Acme United Corp. | 1983-10-31 | 47 | 0 |
| K830704 | ONE TIME DISPOSABLE SKIN STAPLER | Acme United Corp. | 1983-04-12 | 36 | 0 |
| K822865 | SURGI-SCRUB V | Acme United Corp. | 1982-10-18 | 21 | 0 |
| K811625 | PREP-SITE PROTECTIVE DRESSING WIPE | Acme United Corp. | 1981-07-10 | 31 | 0 |
| K811120 | SURGICAL STAPLE REMOVER | Acme United Corp. | 1981-05-05 | 11 | 0 |
| K801884 | OP-SITE SKIN CLOSURE SUTURE ADHESIVE | Acme United Corp. | 1980-10-10 | 64 | 0 |
| K791573 | JELONET PARAFFIN GAUZE DRESSINGS | Acme United Corp. | 1979-09-04 | 25 | 0 |
| K791369 | AIRSTRIP THEATRE WARD DRESSING | Acme United Corp. | 1979-08-28 | 35 | 0 |
| K780853 | OP-SITE ADHESIVE DRAPES | Acme United Corp. | 1978-08-14 | 84 | 0 |
| K770481 | SHEAR, PLASTIC HANDLE UTILITY S-475-7 | Acme United Corp. | 1977-04-29 | 49 | 0 |
| K770414 | PROBE RETRACTOR, PART #S-2L8-6 | Acme United Corp. | 1977-04-15 | 42 | 0 |
| K770418 | RETRACTOR, SKIN HOOK | Acme United Corp. | 1977-03-23 | 19 | 0 |
| K760507 | FORCEP, THUMB | Acme United Corp. | 1976-11-12 | 81 | 0 |
| K760703 | SPONGE AND GAUZE FORCEP PART #S-417-9 | Acme United Corp. | 1976-10-21 | 28 | 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