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

Phoenix Biomedical Corp. — Predicate Candidate Screening

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

90 daysmedian FDA review time
245 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K030468ACURA ELITE GRAVITY COMPENSATING RESERVOIRPhoenix Biomedical Corp.2003-10-152450
K024101PHOENIX UNIVERSAL SHUNT SYSTEMPhoenix Biomedical Corp.2003-01-27460
K024040ACCURA ELITE SHUNT SYSTEMPhoenix Biomedical Corp.2003-01-27520
K021644PERF (OMMAYA STYLE) RESERVOIRSPhoenix Biomedical Corp.2002-08-06780
K002476LUMBOPERITONEAL SHUNT SYSTEMPhoenix Biomedical Corp.2000-11-09900
K000514RUMBAR DRAINAGE SYSTEMPhoenix Biomedical Corp.2000-05-10840
K991429DIAMOND II VALVEPhoenix Biomedical Corp.1999-05-19230
K990256CRX WORLD SHUNTPhoenix Biomedical Corp.1999-04-01640
K974096CRX DIAMOND VALVEPhoenix Biomedical Corp.1998-12-084040
K962144PHOENIX ETE TISSUE EXTENSION SYSTEMPhoenix Biomedical Corp.1997-01-142250
K960435PHOENIX CRX VALVEPhoenix Biomedical Corp.1996-08-272090
K953128SUTURE CORDPhoenix Biomedical Corp.1996-02-092180

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