Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bivona Medical Technologies · Predicate Candidate Screening
50 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
188 days90th percentile
50clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952700 | SUPERSLICK | Bivona Medical Technologies | 1995-10-31 | 140 | 0 |
| K942025 | BURGET NASAL STENT | Bivona Medical Technologies | 1995-10-27 | 549 | 0 |
| K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | Bivona Medical Technologies | 1994-10-27 | 62 | 0 |
| K935053 | BIVONA NASAL TURBINATE STENT | Bivona Medical Technologies | 1994-07-01 | 253 | 0 |
| K933398 | BIVONA ILLUMINATED ENDOTRACHEAL TUBE | Bivona Medical Technologies | 1993-10-06 | 86 | 0 |
| K931749 | BIVONA(R) ICU ENDOTRACHEAL TUBE | Bivona Medical Technologies | 1993-08-10 | 124 | 0 |
| K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1993-01-07 | 220 | 5 |
| K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | Bivona Medical Technologies | 1992-12-29 | 148 | 1 |
| K920604 | BIVONA TRACHEAL T-TUBE STENT | Bivona Medical Technologies | 1992-07-27 | 167 | 0 |
| K915761 | BIVONA-COLORADO VOICE PROSTHESIS | Bivona Medical Technologies | 1992-06-29 | 188 | 0 |
| K915799 | BIVONA SLEEP APNEA TUBE | Bivona Medical Technologies | 1992-02-03 | 41 | 0 |
| K913859 | BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION | Bivona Medical Technologies | 1992-01-30 | 156 | 2 |
| K914088 | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1991-10-23 | 42 | 2 |
| K914183 | BIVONA CUFF MAINTENANCE DEVICE (CMD) | Bivona Medical Technologies | 1991-10-23 | 35 | 0 |
| K913270 | BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1991-08-09 | 17 | 0 |
| K912967 | BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH. | Bivona Medical Technologies | 1991-07-17 | 9 | 0 |
| K912469 | BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1991-06-19 | 15 | 44 |
| K905052 | BIVONA ENDOTRACHEAL TUBE STYLET | Bivona Medical Technologies | 1991-04-02 | 145 | 0 |
| K900583 | MODIFIED BIVONA EPISTAXIS CATHETER | Bivona Medical Technologies | 1990-08-09 | 183 | 0 |
| K901603 | MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER | Bivona Medical Technologies | 1990-05-04 | 38 | 0 |
| K896547 | MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1990-01-22 | 68 | 0 |
| K896548 | MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1990-01-22 | 68 | 0 |
| K895946 | BIVONA CARDEN INTERMITTENT JETTING DEVICE | Bivona Medical Technologies | 1990-01-09 | 90 | 0 |
| K891239 | MOP CATHETER | Bivona Medical Technologies | 1989-11-28 | 266 | 0 |
| K894613 | BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1989-10-13 | 85 | 1 |
| K894614 | BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1989-10-13 | 85 | 2 |
| K892888 | EXTACISER PERINEAL MUSCLE EXERCISER | Bivona Medical Technologies | 1989-10-05 | 168 | 0 |
| K890499 | BIVONA VENTILATOR ISOLATOR SYSTEM | Bivona Medical Technologies | 1989-06-15 | 134 | 0 |
| K885129 | MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1989-02-27 | 77 | 0 |
| K885130 | MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE | Bivona Medical Technologies | 1989-02-27 | 77 | 0 |
| K884427 | FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT. | Bivona Medical Technologies | 1988-11-02 | 13 | 0 |
| K881011 | BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS | Bivona Medical Technologies | 1988-05-13 | 64 | 0 |
| K881744 | PORGES URETERAL STENT | Bivona Medical Technologies | 1988-05-03 | 11 | 0 |
| K872366 | AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE | Bivona Medical Technologies | 1987-08-17 | 60 | 0 |
| K862238 | BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE | Bivona Medical Technologies | 1986-10-15 | 125 | 0 |
| K862267 | FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES | Bivona Medical Technologies | 1986-06-18 | 5 | 0 |
| K861088 | BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS | Bivona Medical Technologies | 1986-04-02 | 12 | 0 |
| K853502 | VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY | Bivona Medical Technologies | 1985-10-01 | 41 | 0 |
| K852272 | BIVONA TRACHEOSTOMA VALVE II | Bivona Medical Technologies | 1985-07-08 | 41 | 0 |
| K850703 | SAF T FLO VENTILATOR TUBING | Bivona Medical Technologies | 1985-03-25 | 32 | 0 |
| K823749 | LOW PRESSURE BLOM-SINGER VOICE PROSTHES | Bivona Medical Technologies | 1983-01-07 | 25 | 0 |
| K820672 | HASSON BUEC-3 | Bivona Medical Technologies | 1982-07-30 | 141 | 0 |
| K821568 | BLOW-SINGER TRACHEOSTOMA VALVE | Bivona Medical Technologies | 1982-07-26 | 60 | 1 |
| K821584 | EPISTAXIS CATHETER/KIT | Bivona Medical Technologies | 1982-06-14 | 13 | 0 |
| K820737 | PERISCOPE VOICE PROSTHESIS | Bivona Medical Technologies | 1982-04-09 | 22 | 0 |
| K812982 | BLOM-SINGER VOICE PROSTHESIS | Bivona Medical Technologies | 1981-11-24 | 32 | 0 |
| K810436 | TRACHEOSTOMA VENT | Bivona Medical Technologies | 1981-03-04 | 13 | 0 |
| K800563 | BLOM-SINGER DUCKBILL VOICE PROSTHESIS | Bivona Medical Technologies | 1980-03-25 | 12 | 0 |
| K792035 | FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE | Bivona Medical Technologies | 1979-10-26 | 16 | 0 |
| K780583 | FOME-CUF PVC | Bivona Medical Technologies | 1978-05-12 | 30 | 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