Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Myocure, Inc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
98 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880346 | CANNULAS | Myocure, Inc. | 1988-05-03 | 98 | 0 |
| K880347 | ANESTHESIA/RETROBULBAR NEEDLES | Myocure, Inc. | 1988-05-03 | 98 | 0 |
| K880345 | CYSTOTOMES/KNIFES | Myocure, Inc. | 1988-05-03 | 98 | 0 |
| K874057 | OPHTHALMIC TIP & BLADE SCALPELS | Myocure, Inc. | 1987-12-23 | 79 | 0 |
| K874056 | OPHTHALMIC DISPOSABLE BLADES | Myocure, Inc. | 1987-12-22 | 78 | 0 |
| K873385 | OPHTHALMIC PHACO-BLADE | Myocure, Inc. | 1987-09-21 | 28 | 0 |
| K864371 | SURGICAL SKIN MARKER | Myocure, Inc. | 1986-11-17 | 12 | 0 |
| K863663 | OPHTHALMIC SURGICAL OCULAR MARKERS | Myocure, Inc. | 1986-10-20 | 32 | 0 |
| K863666 | THE SAVER KIT | Myocure, Inc. | 1986-10-20 | 32 | 0 |
| K863662 | OPHTHALMIC SURGICAL DRAPE | Myocure, Inc. | 1986-10-20 | 32 | 0 |
| K863664 | OPHTHALMIC SURGICAL SPECULUM | Myocure, Inc. | 1986-09-25 | 7 | 0 |
| K863665 | THE ULTIMATE | Myocure, Inc. | 1986-09-25 | 7 | 0 |
| K844112 | MYOPACH ULTRASONIC PACHOMETER | Myocure, Inc. | 1986-01-16 | 450 | 0 |
| K853598 | OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE | Myocure, Inc. | 1985-11-04 | 69 | 0 |
| K822392 | MYOCUR BLADE PAC | Myocure, Inc. | 1982-08-25 | 16 | 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