Atlas FDA

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

Equilibrated Bio Systems, Inc. — Predicate Candidate Screening

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

37 daysmedian FDA review time
196 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K892705EBS2605 INFANT HUGGEREquilibrated Bio Systems, Inc.1989-10-271960
K855102MONARK 869 ERGOMETEREquilibrated Bio Systems, Inc.1986-05-091370
K843996TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLEREquilibrated Bio Systems, Inc.1984-11-20400
K791294SPIROCALEquilibrated Bio Systems, Inc.1979-08-16370
K790410ADULT ZEE-FRAMEEquilibrated Bio Systems, Inc.1979-03-22240
K781509ZEE-FRAMEEquilibrated Bio Systems, Inc.1978-09-26250
K781386EBS 775 TONOMETEREquilibrated Bio Systems, Inc.1978-09-14340

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