Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro Specialties, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033457 | M2 COMPATIBLE MICROKERATOME BLADE | Micro Specialties, Inc. | 2004-05-25 | 208 | 0 |
| K020482 | KERATOME BLADE 200200 & 600600 | Micro Specialties, Inc. | 2002-12-16 | 306 | 0 |
| K980510 | KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODE | Micro Specialties, Inc. | 1998-05-01 | 80 | 0 |
| K980508 | KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C | Micro Specialties, Inc. | 1998-05-01 | 80 | 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