Atlas FDA

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

National Health-Care Equipment, Inc. · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K913814MODEL #05 ANEROID SPHYGMOMANOMETER KITNational Health-Care Equipment, Inc.1992-01-161430
K913856INFRARED HEAT LAMP MODEL NH-201National Health-Care Equipment, Inc.1991-11-29940
K913880INFRARED HEAT LAMP MODEL NH-202National Health-Care Equipment, Inc.1991-11-29920
K913973INFRARED HEAT LAMPS & MASSAGER MODEL NH-213National Health-Care Equipment, Inc.1991-11-29840

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