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

Thomas Industries — Predicate Candidate Screening

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

129 daysmedian FDA review time
602 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K041199MEDI-PUMP ASPIRATOR, MODEL 1615Thomas Industries2004-06-01250
K965059CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1Thomas Industries1997-03-04763
K952806MEDI PUMP ASPIRATOR MODELS 1130 AND 1135Thomas Industries1995-10-261290
K950290MEDI - PUMPThomas Industries1995-08-242110
K951729MEDI - PUMPThomas Industries1995-08-211290
K950867MEDI - PUMPThomas Industries1995-04-19510
K944399MEDI-PUMPThomas Industries1995-01-181320
K925010NEBULIZER PUMP, POWERED, MODEL 1110Thomas Industries1994-05-276020
K925011NEBULIZER PUMP, POWERED MODEL 1180Thomas Industries1994-01-124670

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