Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pollak (Intl.), Ltd. — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
72 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000227 | UMBICUT | Pollak (Intl.), Ltd. | 2000-04-27 | 94 | 0 |
| K810049 | PEDICAT* | Pollak (Intl.), Ltd. | 1981-04-21 | 98 | 0 |
| K810050 | VECAFIX* | Pollak (Intl.), Ltd. | 1981-03-26 | 72 | 0 |
| K802011 | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 | Pollak (Intl.), Ltd. | 1980-10-31 | 72 | 0 |
| K802009 | FLOWCLAMP CAT.#1011 & 1012 | Pollak (Intl.), Ltd. | 1980-10-31 | 72 | 0 |
| K802017 | DRESSING CHANGE SET CAT.#910-930 | Pollak (Intl.), Ltd. | 1980-10-10 | 51 | 0 |
| K802007 | PEDIWET=GUAZE IMPREGNATED WITH PETROL | Pollak (Intl.), Ltd. | 1980-09-26 | 37 | 0 |
| K802004 | PROFILE SWAB CAT.#5273 & 5274 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K802022 | STERILE GUAZE SWABS CAT.#301-420 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K802016 | EYE APPLICATORS CAT.#980-983 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K802013 | FIRST AID BANDAGE CAT.#198 OR 199 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K802010 | GUAZE SWABS CAT.#251-300 (SIZE & PLY) | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K801991 | PLASTIC FORCEPS CAT.#1001-1010 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K802001 | LAP SPONGES CAT.#801-850 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K802019 | SUTURE REMOVAL SET CAT.#906 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K801996 | GUAZE BANDAGES CAT.#101-169 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K802021 | PEDIBAND CAT.#195-197 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K802006 | TRIANGULAR BANDAGE CAT.#191 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K802005 | ABSORBENT PAD CAT.#729, 732, 730, 731 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K801999 | GUAZE BALLS CAT.#601-720 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K802002 | URINE SPECIMEN CONTAINER #'S 1013-1016 | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 0 |
| K802008 | BREAKING CAST WIRE CAT.#1112-1115 | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 0 |
| K802015 | FINGER PAINGUARD CAT.#193-194 | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 0 |
| K802003 | PLASTIC DISPOSABLE RAZOR CAT.#1017,1018 | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 0 |
| K802012 | TRIBAG, URINE BAG SYSTEM #1109,& 1301-12 | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 0 |
| K801990 | ELASTIC BANDAGE CAT.#182-186 (WIDTH) | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 0 |
| K802023 | CULSWAB CAT.#978 & 979 | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 0 |
| K801995 | EYE PADS CAT.#581-599 | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 0 |
| K801997 | EMBOSSED DISP. POLY. GLOVES #5101-03 | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 0 |
| K801998 | STERILE EXAMINATION GLOVE #5121-5126 | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 0 |
| K802020 | PREP SET CAT.#908 | Pollak (Intl.), Ltd. | 1980-09-09 | 20 | 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