Atlas FDA

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

Medical Equipment Designs, Inc. · Predicate Candidate Screening

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

56 daysmedian FDA review time
173 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K911308CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLEMedical Equipment Designs, Inc.1991-09-111730
K894152MEDITHERMMedical Equipment Designs, Inc.1990-06-113620
K895375MULTISPIROMedical Equipment Designs, Inc.1989-11-27890
K851277MICROSPIRO-SDSMedical Equipment Designs, Inc.1985-04-19180
K840908CHESTAC-25F SPIROMETERMedical Equipment Designs, Inc.1984-05-14750
K840929FRC 85 SERIES SPIROMETERMedical Equipment Designs, Inc.1984-05-14730
K821081CHART PROJECTORMedical Equipment Designs, Inc.1982-06-14560
K821082TRIAL LENS SETMedical Equipment Designs, Inc.1982-06-14560
K821083P.D. METERMedical Equipment Designs, Inc.1982-06-14560
K821084UNIVERSAL TRIAL FRAMEEMedical Equipment Designs, Inc.1982-06-14560
K821107EXOPHTHALMOMETERMedical Equipment Designs, Inc.1982-06-14550
K821080HAND KERATOSCOPEMedical Equipment Designs, Inc.1982-05-24350
K820599AUTOSPIROMETER HI-498Medical Equipment Designs, Inc.1982-04-15420

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