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

Associated Mills, Inc. — Predicate Candidate Screening

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

48 daysmedian FDA review time
164 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K901459DS60 TOOTHBRUSH SANITIZERAssociated Mills, Inc.1990-09-171730
K872327WHIRLPOOL AERATOR WB700, WB800, WB900, WB975Associated Mills, Inc.1987-09-04790
K871661WH150 ROOM HUMIDIFIERAssociated Mills, Inc.1987-06-15480
K862041WM10, WM20, WM30 POWER MASSAGERAssociated Mills, Inc.1986-06-17200
K862042SH20, SH30 & SH50 ULTRASONIC HUMIDIFIERAssociated Mills, Inc.1986-06-0580
K844397POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000Associated Mills, Inc.1985-04-181560
K844396POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000Associated Mills, Inc.1985-04-181560
K850362POLLENEX DIGITAL THERMOMETER T-125Associated Mills, Inc.1985-02-15160
K850363POLLENEX DIGITAL THERMOMETER T-225Associated Mills, Inc.1985-02-15160
K841095BP800, 850 1000Associated Mills, Inc.1984-08-241640
K841100HP-20, 30, 40, 50 & 60Associated Mills, Inc.1984-03-23100
K810034FOOT BATHS & HAND MASSAGERSAssociated Mills, Inc.1981-01-1590
K800251MT-10, ET-20Associated Mills, Inc.1980-04-02560
K800250HMB-200Associated Mills, Inc.1980-03-25480

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