Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Norm Pacific Automation Corp. · Predicate Candidate Screening

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

53 daysmedian FDA review time
79 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K051835NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702Norm Pacific Automation Corp.2005-09-23790
K031907NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351; ET 4Norm Pacific Automation Corp.2003-08-21620
K030126NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,60Norm Pacific Automation Corp.2003-02-07240
K011704NPAC EAR THERMOMETER MODEL TD 402Norm Pacific Automation Corp.2001-06-27260
K010224NPAC MULTI-USE THERMOMETER, MODEL TD400Norm Pacific Automation Corp.2001-03-18530

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