Atlas FDA

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

Intl. Medical Equipment Corp. · Predicate Candidate Screening

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

28 daysmedian FDA review time
36 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K832745OC3 FLYERIntl. Medical Equipment Corp.1983-09-20360
K832321ACCES. HEAD CONTROL-POWERED CHEELCHAIRIntl. Medical Equipment Corp.1983-08-12280
K832322BASE ONLY, TORONTO CHAIRIntl. Medical Equipment Corp.1983-08-12280
K832325BASE ONLY, POWER WHEELCHAIRIntl. Medical Equipment Corp.1983-08-12280
K813104POWER DRIVE WHEELCRIntl. Medical Equipment Corp.1981-11-20170
K803307MATTRESS, AIR FLOATATION, ALTERN. PRESS.Intl. Medical Equipment Corp.1981-01-13140

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