Atlas FDA

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

Hydro-Med Products, Inc. · Predicate Candidate Screening

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

92 daysmedian FDA review time
315 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K944198SURGICAL MICROSCOPE DRAPEHydro-Med Products, Inc.1994-11-27900
K940151ULTRASOUND PROBE DRAPEHydro-Med Products, Inc.1994-11-143151
K940152CAMERA COVER WITH TEAR TIPHydro-Med Products, Inc.1994-10-282980
K934630UNIVERSAL VIDEO/LASER ARM DRAPEHydro-Med Products, Inc.1994-10-283990
K923099X-RAY DRAPESHydro-Med Products, Inc.1992-10-151120
K863872TAMPER HAMPERHydro-Med Products, Inc.1987-02-101300
K853281EASYTOPHydro-Med Products, Inc.1985-08-21160
K842304THE PATHFINDERHydro-Med Products, Inc.1984-08-01510
K834407STERILE DISPOSABLE SPINAL NEEDLESHydro-Med Products, Inc.1984-03-19960
K812405STERILE TV CAMERA & CORD COVERHydro-Med Products, Inc.1981-10-20600
K790659INFANT SCALE DISPOSABLE LINERHydro-Med Products, Inc.1979-04-30260
K780905LIMB COVERHydro-Med Products, Inc.1978-08-14730
K780452THERA-PAKHydro-Med Products, Inc.1978-06-21920

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