Atlas FDA

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

Rocky Mountain Medical Corp. · Predicate Candidate Screening

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

56 daysmedian FDA review time
182 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K890202TELE-TEMP THERMOMETERRocky Mountain Medical Corp.1989-04-05780
K860120NURSERY AMBIENT LIGHT METERRocky Mountain Medical Corp.1986-02-19370
K852167ISOVOL-EXCHANGE TRAYRocky Mountain Medical Corp.1985-11-181820
K853970ALPHA CHUCKRocky Mountain Medical Corp.1985-11-08430
K853790BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCERRocky Mountain Medical Corp.1985-10-04240
K851876PREFER INCONTINENCE AIDRocky Mountain Medical Corp.1985-06-12440
K834430OMNI INFANT PHOTOTHERAPY UNITRocky Mountain Medical Corp.1984-04-301360
K832298BABY LIGHT DOSIMETERRocky Mountain Medical Corp.1983-10-19970
K837494BABY LIGHT METERRocky Mountain Medical Corp.1983-06-14560

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