Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Teleflex, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
183 daysmedian FDA review time
518 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter K | Teleflex, Inc. | 2016-06-21 | 183 | 0 |
| K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERA | Teleflex, Inc. | 2015-03-27 | 436 | 5 |
| K141940 | CONCHASMART COLUMN | Teleflex, Inc. | 2014-11-24 | 130 | 0 |
| K140556 | CONCHASMART BREATHING CIRCUIT | Teleflex, Inc. | 2014-09-24 | 203 | 0 |
| K131912 | CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFIC | Teleflex, Inc. | 2014-03-06 | 253 | 3 |
| K123974 | PERCUTANEOUS INTRODUCER KIT | Teleflex, Inc. | 2013-02-21 | 57 | 0 |
| K121403 | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET | Teleflex, Inc. | 2012-06-20 | 41 | 3 |
| K103658 | FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER | Teleflex, Inc. | 2012-05-16 | 518 | 3 |
| K861951 | MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER | Teleflex, Inc. | 1986-06-19 | 30 | 0 |
| K860307 | PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET | Teleflex, Inc. | 1986-05-20 | 112 | 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