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

Health Products, Inc. · Predicate Candidate Screening

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

69 daysmedian FDA review time
209 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K912866PEAK EXPIRATORY FLOW METERHealth Products, Inc.1992-08-134120
K912943THRESHOLD 2X INSPIRATORY MUSCLE TRAINERHealth Products, Inc.1992-01-302090
K911807METERED DOSE INHALER (MDI) SPACERHealth Products, Inc.1991-10-231830
K902292MODIFIED ASSESS(R) PEAK FLOW METERHealth Products, Inc.1990-08-10800
K896953MODIFIED ASSESS(R) PEAK FLOW METERHealth Products, Inc.1990-01-30560
K894353ORTHODERM CONVERTIBLEHealth Products, Inc.1989-08-09260
K890426CONSUMMATE AIR THERAPY BEDHealth Products, Inc.1989-04-05690
K874801ORTHODERM THERAPY BEDHealth Products, Inc.1988-02-05740
K871742MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINERHealth Products, Inc.1987-06-15410
K870514THRESHOLD(TM) INSPIRATORY MUSCLE TRAINERHealth Products, Inc.1987-03-31540
K864719PFLEX EM(TM) (EXERCISE MONITOR)Health Products, Inc.1987-03-161030
K864918HEALTH PRODUCTS, INC. ORTHODERM THERAPY CHAIRHealth Products, Inc.1986-12-2480
K862128DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER)Health Products, Inc.1986-07-11370

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