B&B Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “B&B Medical Technologies, Inc.” (first 1986, latest 2004), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | 8 | 8 |
| CAF | Nebulizer (Direct Patient Interface) | 6 | 6 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 2 |
| BZA | Connector, Airway (Extension) | 2 | 2 |
| BXY | Flowmeter, Calibration, Gas | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| HXD | Clamp | 1 | 1 |
| JAY | Support, Breathing Tube | 1 | 1 |
| JXL | Block, Bite | 1 | 1 |
Review panels
- Anesthesiology (21)
- Neurology (1)
- General and Plastic Surgery (1)
Most recent B&B Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030396 | OMNI~NEB; OMNI~MAX | CAF | 2004-05-07 | 456 |
| K980407 | HOPE NEBULIZER | CAF | 1998-05-27 | 113 |
| K960663 | UNIVERSAL BITE BLOCK | JXL | 1996-05-17 | 91 |
| K945816 | QUICK-LOCK | BTR | 1995-01-13 | 46 |
| K944324 | SURE-LOCK VENTILATOR TUBING HOLDER | BTR | 1994-11-04 | 63 |
| K935171 | STABILTRACH | CBH | 1993-12-02 | 37 |
| K925386 | ADHESIVE E.T. TAPE | CBH | 1993-04-19 | 175 |
| K923690 | MINI HEART | CAF | 1992-10-20 | 88 |
| K913015 | HEART NEBULIZER FLOWMETER ADAPTOR | CAF | 1991-11-20 | 135 |
| K913753 | BODAI NEO2 -SAFE AIRWAY PRESSURE CAP | CAI | 1991-10-23 | 63 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named B&B Medical Technologies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under B&B Medical Technologies, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under B&B Medical Technologies, Inc.?
FDA lists 23 510(k) clearances under the applicant name “B&B Medical Technologies, Inc.” (first 1986, latest 2004), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by B&B Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name B&B Medical Technologies, Inc. is 60 days.
Which FDA product codes appear under B&B Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are CBH (Device, Fixation, Tracheal Tube, 8); CAF (Nebulizer (Direct Patient Interface), 6); BTR (Tube, Tracheal (W/Wo Connector), 2).
Next steps
- See all 23 B&B Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBH, B&B Medical Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.