Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neotech Products, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
142 daysmedian FDA review time
227 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011564 | NEOLEAD | Neotech Products, Inc. | 2002-01-03 | 227 | 0 |
| K931727 | URINARY DRAINAGE BAG CADDY | Neotech Products, Inc. | 1993-07-23 | 142 | 0 |
| K921024 | URO-TOTE LEG BAG | Neotech Products, Inc. | 1992-09-02 | 183 | 0 |
| K890425 | NEOTECH MUCUS TRAP W/CATHETER | Neotech Products, Inc. | 1989-04-19 | 83 | 0 |
| K882203 | NEOTECH UNIVERSAL ADAPTER | Neotech Products, Inc. | 1988-06-17 | 23 | 0 |
| K880487 | NEOTECH MECONIUM ASPIRATOR (STERILE) | Neotech Products, Inc. | 1988-05-06 | 92 | 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