B&B Medical Assoc., Inc.: FDA clearances and approvals
B&B Medical Assoc., Inc. has 5 FDA 510(k) clearances (first 1988, latest 1988), across 3 product codes in 2 review panels. Median 510(k) review time: 149 days.
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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 2 | 2 |
| KYG | Device, Irrigation, Ocular Surgery | 2 | 2 |
| FIH | Pump, Infusion Or Syringe, Extra-Luminal | 1 | 1 |
Review panels
Most recent B&B Medical Assoc., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K881707 | INTROCULAR FLUID INJECTOR | FIH | 1988-10-21 | 193 |
| K881519 | VAC-G (GUILLOTINE VITRECTOR) | HQE | 1988-09-08 | 150 |
| K881520 | VAC (OSCILLATING VITRECTOR) | HQE | 1988-09-07 | 149 |
| K881518 | INFUSION HANDLE | KYG | 1988-08-22 | 133 |
| K881517 | B & B I/A HANDPIECE | KYG | 1988-08-22 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named B&B Medical Assoc., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of B&B Medical Assoc., Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does B&B Medical Assoc., Inc. have?
B&B Medical Assoc., Inc. has 5 FDA 510(k) clearances (first 1988, latest 1988), across 3 product codes in 2 review panels.
How long does FDA take to clear B&B Medical Assoc., Inc.'s 510(k)s?
The median time from FDA receipt to decision across B&B Medical Assoc., Inc.'s cleared 510(k)s is 149 days.
What devices does B&B Medical Assoc., Inc. make?
Its most frequent FDA product codes are HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered, 2); KYG (Device, Irrigation, Ocular Surgery, 2); FIH (Pump, Infusion Or Syringe, Extra-Luminal, 1).
Has B&B Medical Assoc., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching B&B Medical Assoc., Inc. Related entities may recall under other names.
Next steps
- See all 5 B&B Medical Assoc., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQE, B&B Medical Assoc., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.