Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
G.W.B. Intl., Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
106 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955671 | RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) | G.W.B. Intl., Ltd. | 1996-03-06 | 93 | 0 |
| K954094 | OPHTA SIL- PUNCTAL PLUGS (MODIFICATION) | G.W.B. Intl., Ltd. | 1995-10-05 | 42 | 0 |
| K950569 | OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)} | G.W.B. Intl., Ltd. | 1995-03-14 | 41 | 0 |
| K940508 | OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) | G.W.B. Intl., Ltd. | 1994-05-04 | 89 | 0 |
| K911110 | OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS | G.W.B. Intl., Ltd. | 1991-06-18 | 106 | 0 |
| K911108 | OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS | G.W.B. Intl., Ltd. | 1991-05-13 | 70 | 0 |
| K911109 | OPHTA SIL (R), LACHRYMAL INTUBATION SETS | G.W.B. Intl., Ltd. | 1991-05-01 | 58 | 0 |
| K896029 | DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20 | G.W.B. Intl., Ltd. | 1990-01-12 | 87 | 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