Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Burron Medical, Inc. · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

132 daysmedian FDA review time
515 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K902401CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEMBurron Medical, Inc.1991-10-084960
K896422BURRON AMBULATORY DRUG DELIVERY SYSTEMBurron Medical, Inc.1990-05-091820
K884235COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KITBurron Medical, Inc.1990-03-065150
K895191ANTI-THROMBOGENIC COATING FOR CATHETERSBurron Medical, Inc.1989-11-241050
K895192SPINOCAN(R) CONTINUOUS SPINAL TRAYBurron Medical, Inc.1989-09-18380
K884183BURRON TEFLON-COATED GUIDEWIREBurron Medical, Inc.1989-08-033030
K882106PERFUSOR M SYRINGE PUMPBurron Medical, Inc.1988-08-11850
K882107PERFUSOR SECURA SYRINGE PUMPBurron Medical, Inc.1988-08-11840
K881342IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEMBurron Medical, Inc.1988-08-091320

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