Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
B&B Medical Technologies, Inc. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
175 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030396 | OMNI~NEB; OMNI~MAX | B&B Medical Technologies, Inc. | 2004-05-07 | 456 | 0 |
| K980407 | HOPE NEBULIZER | B&B Medical Technologies, Inc. | 1998-05-27 | 113 | 0 |
| K960663 | UNIVERSAL BITE BLOCK | B&B Medical Technologies, Inc. | 1996-05-17 | 91 | 0 |
| K945816 | QUICK-LOCK | B&B Medical Technologies, Inc. | 1995-01-13 | 46 | 0 |
| K944324 | SURE-LOCK VENTILATOR TUBING HOLDER | B&B Medical Technologies, Inc. | 1994-11-04 | 63 | 0 |
| K935171 | STABILTRACH | B&B Medical Technologies, Inc. | 1993-12-02 | 37 | 0 |
| K925386 | ADHESIVE E.T. TAPE | B&B Medical Technologies, Inc. | 1993-04-19 | 175 | 0 |
| K923690 | MINI HEART | B&B Medical Technologies, Inc. | 1992-10-20 | 88 | 0 |
| K913015 | HEART NEBULIZER FLOWMETER ADAPTOR | B&B Medical Technologies, Inc. | 1991-11-20 | 135 | 0 |
| K913753 | BODAI NEO2 -SAFE AIRWAY PRESSURE CAP | B&B Medical Technologies, Inc. | 1991-10-23 | 63 | 0 |
| K913000 | HEART NEBULIZER POLE CLAMP | B&B Medical Technologies, Inc. | 1991-08-02 | 25 | 0 |
| K912884 | E.T. TAPE II | B&B Medical Technologies, Inc. | 1991-07-31 | 30 | 0 |
| K900912 | BABY E.T. TAPE II | B&B Medical Technologies, Inc. | 1990-08-03 | 157 | 0 |
| K902065 | E.T. TAPE II | B&B Medical Technologies, Inc. | 1990-07-23 | 76 | 0 |
| K900787 | NASAL E.T. TAPE | B&B Medical Technologies, Inc. | 1990-03-16 | 24 | 0 |
| K900228 | H.E.A.R.T. NEBULIZER | B&B Medical Technologies, Inc. | 1990-03-16 | 58 | 0 |
| K881849 | BODAI M.D.D. ADAPTOR(TM) | B&B Medical Technologies, Inc. | 1988-07-01 | 60 | 0 |
| K873696 | BODAI NEO2-SAFE(TM) | B&B Medical Technologies, Inc. | 1988-04-14 | 213 | 0 |
| K873491 | BLOCK, BITE, INTUBATION | B&B Medical Technologies, Inc. | 1987-10-20 | 50 | 0 |
| K871560 | BABY E.T. TAPE(TM) | B&B Medical Technologies, Inc. | 1987-05-22 | 30 | 0 |
| K863510 | OXY-OFF(TM) | B&B Medical Technologies, Inc. | 1986-10-22 | 43 | 0 |
| K863653 | SUCTION-OFF | B&B Medical Technologies, Inc. | 1986-10-07 | 19 | 0 |
| K862084 | E. T. TAPE ENDOTRACHEAL TUBE HOLDER | B&B Medical Technologies, Inc. | 1986-06-05 | 3 | 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