Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
B&B Medical Assoc., Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
193 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K881707 | INTROCULAR FLUID INJECTOR | B&B Medical Assoc., Inc. | 1988-10-21 | 193 | 0 |
| K881519 | VAC-G (GUILLOTINE VITRECTOR) | B&B Medical Assoc., Inc. | 1988-09-08 | 150 | 0 |
| K881520 | VAC (OSCILLATING VITRECTOR) | B&B Medical Assoc., Inc. | 1988-09-07 | 149 | 0 |
| K881517 | B & B I/A HANDPIECE | B&B Medical Assoc., Inc. | 1988-08-22 | 133 | 0 |
| K881518 | INFUSION HANDLE | B&B Medical Assoc., Inc. | 1988-08-22 | 133 | 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