Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Burron Medical Products, Inc. · Predicate Candidate Screening
41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
132 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870403 | CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE | Burron Medical Products, Inc. | 1987-05-01 | 88 | 0 |
| K862412 | INTESTOPLANT | Burron Medical Products, Inc. | 1986-11-13 | 141 | 0 |
| K861479 | CAVAFIX, CENTRAL VENOUS CATHETER KIT | Burron Medical Products, Inc. | 1986-07-01 | 70 | 0 |
| K860126 | STIMUPLEX, NERVE STIMULATOR | Burron Medical Products, Inc. | 1986-02-28 | 45 | 4 |
| K851293 | IMPLANTOFIX | Burron Medical Products, Inc. | 1986-01-09 | 283 | 0 |
| K841428 | JEJUNOSTOMY SET FOR TUBE FEEDING | Burron Medical Products, Inc. | 1984-07-09 | 94 | 0 |
| K834299 | LONG TERM CENTRAL VENOUS ACCESS CATH | Burron Medical Products, Inc. | 1984-05-01 | 145 | 0 |
| K834383 | DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT | Burron Medical Products, Inc. | 1984-05-01 | 139 | 0 |
| K834473 | MULTI-LUMEN CENTRAL VENOUS CATH. KIT | Burron Medical Products, Inc. | 1984-04-30 | 132 | 0 |
| K840179 | CONTINUOUS EPIDURAL ANESTHES. TRAY | Burron Medical Products, Inc. | 1984-02-24 | 38 | 0 |
| K840287 | BRACHIAL PLEXUS ANESTHESIA TRAY | Burron Medical Products, Inc. | 1984-02-23 | 30 | 0 |
| K830571 | BOTTLE ADAPTER | Burron Medical Products, Inc. | 1983-03-24 | 29 | 0 |
| K830572 | CLEAN-FLUSH | Burron Medical Products, Inc. | 1983-03-17 | 22 | 0 |
| K830193 | CAT 3040 | Burron Medical Products, Inc. | 1983-03-09 | 48 | 0 |
| K820453 | THE INT-STOPPER | Burron Medical Products, Inc. | 1982-03-08 | 18 | 0 |
| K820454 | THE RED CAP | Burron Medical Products, Inc. | 1982-03-08 | 18 | 0 |
| K820004 | PLEUROFIX THORACENTESIS KIT | Burron Medical Products, Inc. | 1982-02-04 | 31 | 0 |
| K820047 | SPINOCAN SPINAL NEEDLE | Burron Medical Products, Inc. | 1982-01-25 | 17 | 1 |
| K813396 | VERSCHLUBSTOPFEN COMB-CLOSING STOPPER | Burron Medical Products, Inc. | 1982-01-12 | 39 | 0 |
| K813498 | MEDIFIX | Burron Medical Products, Inc. | 1982-01-07 | 24 | 0 |
| K813082 | UREOFIX 500 URINE MEASURING SYSTEM | Burron Medical Products, Inc. | 1981-12-31 | 59 | 0 |
| K813084 | CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET | Burron Medical Products, Inc. | 1981-12-31 | 59 | 0 |
| K813259 | IN-STOPPER (INJECTION CAP | Burron Medical Products, Inc. | 1981-12-31 | 41 | 0 |
| K813081 | HISTOCAN BIOPSY NEEDLE | Burron Medical Products, Inc. | 1981-12-29 | 57 | 0 |
| K813195 | MEDIFIX GRADUATED SCALE | Burron Medical Products, Inc. | 1981-12-29 | 47 | 0 |
| K813165 | PLEXUFIX BRACHIAL PLEXUS ANESTH. NEEDLE | Burron Medical Products, Inc. | 1981-12-03 | 23 | 0 |
| K813179 | PERICAN, EPIDURAL CANNULA | Burron Medical Products, Inc. | 1981-12-03 | 21 | 0 |
| K813186 | PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO | Burron Medical Products, Inc. | 1981-12-03 | 17 | 0 |
| K813236 | EPICAN EPIDURAL CANNULA, BEVEL ACCORD | Burron Medical Products, Inc. | 1981-12-03 | 23 | 0 |
| K813085 | HEPAFIX BIOPSY NEEDLE SET | Burron Medical Products, Inc. | 1981-11-20 | 18 | 0 |
| K813083 | VENOFIX SCALP VEIN SET | Burron Medical Products, Inc. | 1981-11-16 | 14 | 0 |
| K810460 | BURRON PERCUTANEOUS INDUCER SET | Burron Medical Products, Inc. | 1981-03-11 | 19 | 0 |
| K810461 | BURRON CENTRAL VEIN CATHERIZATION KIT | Burron Medical Products, Inc. | 1981-03-11 | 19 | 0 |
| K801941 | BURRON MICROCATH INTRA. CATH. PLACEMENTT | Burron Medical Products, Inc. | 1980-08-27 | 14 | 0 |
| K801605 | BIMECO FILTERED EXTENSION SET | Burron Medical Products, Inc. | 1980-08-12 | 28 | 0 |
| K801311 | BURRON MULTI-AD SYRINGE CAP | Burron Medical Products, Inc. | 1980-06-17 | 14 | 0 |
| K801008 | MULTI-AD FLUID DISPENSING PUMP MP-3000 | Burron Medical Products, Inc. | 1980-06-02 | 35 | 0 |
| K801107 | DOUBLE ENDED FILTERED TRANSFER NEEDLE | Burron Medical Products, Inc. | 1980-05-30 | 21 | 0 |
| K801108 | DOUBLE ENDED VENTED TRANSFER DEVICE | Burron Medical Products, Inc. | 1980-05-30 | 21 | 0 |
| K800437 | SYRINGE TIP CONNECTOR | Burron Medical Products, Inc. | 1980-03-12 | 14 | 0 |
| K791020 | FLUID ADMINISTRATION SET FA-3160 | Burron Medical Products, Inc. | 1979-06-27 | 26 | 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