Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Retractable Technologies, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
372 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202325 | EasyPoint Blood Collection Plus | Retractable Technologies, Inc. | 2021-04-09 | 235 | 0 |
| K133635 | EASYPOINT NEEDLE | Retractable Technologies, Inc. | 2014-06-17 | 203 | 1 |
| K122355 | VANISHPOINT BLOOD COLLECTION SET | Retractable Technologies, Inc. | 2013-08-23 | 385 | 0 |
| K112512 | VANISHPOINT BLOOD COLLECTION SET | Retractable Technologies, Inc. | 2011-10-20 | 51 | 0 |
| K101708 | PATIENT SAFE LUER CAP | Retractable Technologies, Inc. | 2011-02-24 | 252 | 0 |
| K081420 | VANISHPOINT I.V. CATHETER | Retractable Technologies, Inc. | 2008-11-07 | 171 | 0 |
| K072654 | PATIENT SAFE SYRINGE | Retractable Technologies, Inc. | 2007-12-14 | 85 | 0 |
| K051355 | VANISHPOINT I.V. CATHETER | Retractable Technologies, Inc. | 2005-09-23 | 122 | 0 |
| K980069 | VANISHPOINT SYRINGE | Retractable Technologies, Inc. | 1998-02-12 | 35 | 0 |
| K973301 | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOI | Retractable Technologies, Inc. | 1997-11-07 | 66 | 0 |
| K971763 | BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL T | Retractable Technologies, Inc. | 1997-08-26 | 105 | 0 |
| K970803 | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOI | Retractable Technologies, Inc. | 1997-05-29 | 86 | 0 |
| K946219 | POP-N-LOK SYRINGE | Retractable Technologies, Inc. | 1995-12-28 | 372 | 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