Atlas FDA

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

Schiff & Co. — Predicate Candidate Screening

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

147 daysmedian FDA review time
326 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K990511X-TIP INTRAOSSEOUS PERFORATORSchiff & Co.1999-04-27680
K982136JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200Schiff & Co.1999-03-242800
K981629NUTRISAFE ENTERAL FEEDING TUBESchiff & Co.1999-02-042730
K981630VYGON DOUBLE LUMEN UMBILICAL CATHETERSchiff & Co.1998-10-011470
K974141PLUS REUSABLE RESUSCITATORSchiff & Co.1998-05-211990
K954448VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEMSchiff & Co.1996-10-283990
K955085HM-CAP EIA TEST (MODIFICATION)Schiff & Co.1996-02-091060
K944159HM-CAP EIA KITSchiff & Co.1995-07-183260
K943521VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURESchiff & Co.1995-02-142090
K896684KEMBLE LIQUID HANDLING SYSTEM DISPENSERSchiff & Co.1990-04-161390
K894617OLYMPUS PK-TP SYSTEM REACTIVE CONTROLSchiff & Co.1989-10-311030
K895967FASTEC 901 AGGLUTINATION PATTERN READERSchiff & Co.1989-10-30180
K882539CLEANTECH SYSTEMSchiff & Co.1988-08-08480
K874482REVISED IMMUDIA HEM-SPSchiff & Co.1988-05-132060
K873986BETA-HCG ASSAYSchiff & Co.1988-02-021260

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