Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Needle Tech Products, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143252 | Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 | Needle Tech Products, Inc. | 2015-04-23 | 161 | 0 |
| K100665 | MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX | Needle Tech Products, Inc. | 2010-06-24 | 108 | 0 |
| K031173 | NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, | Needle Tech Products, Inc. | 2003-07-23 | 100 | 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