Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Technical Products — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
118 daysmedian FDA review time
264 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940083 | STANDARD PHACO TIP 15, 30, 45, 60 | Medical Technical Products | 1994-09-28 | 264 | 0 |
| K940088 | MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE | Medical Technical Products | 1994-08-04 | 209 | 0 |
| K940084 | MODEL 2000 OPHTHALMIC SURGICAL SYSTEM | Medical Technical Products | 1994-06-17 | 161 | 0 |
| K910335 | MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA | Medical Technical Products | 1991-03-13 | 47 | 0 |
| K905251 | MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A | Medical Technical Products | 1991-02-07 | 78 | 0 |
| K904612 | I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM) | Medical Technical Products | 1990-12-26 | 76 | 0 |
| K871473 | PART #860065 IA PAK & PART #860060 IA PAK | Medical Technical Products | 1987-08-10 | 118 | 0 |
| K871474 | PART #860070 ULTRAPAK & #860075 ULTRAPAK | Medical Technical Products | 1987-08-10 | 118 | 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