Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Tiger Medical Products, Ltd. · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

122 daysmedian FDA review time
305 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K122717FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASKTiger Medical Products, Ltd.2012-12-211070
K120690INSULIN PEN NEEDLETiger Medical Products, Ltd.2012-06-221070
K110697TIGER SYRINGES AND NEEDLESTiger Medical Products, Ltd.2011-07-141220
K102713TIGER FLAT SURGICAL MASKTiger Medical Products, Ltd.2011-01-251270
K041311TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)Tiger Medical Products, Ltd.2005-03-183050

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