Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

INW — Predicate Candidate Screening

35 FDA 510(k) clearances under this product code; the 50 most recent screened below.

28 daysmedian FDA review time
111 days90th percentile
35clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K944308JAMES LECKEY FREE STANDERJames Leckey Design1994-12-221110
K944307JAMES LECKEY PRONE STANDERJames Leckey Design1994-12-221110
K943974EURO TECH MARQUISE CHIROPRACTIC TABLEProgressive Electrical Therapeutics1994-09-29450
K943975EURO TECH PLATINUM CHIROPRACTIC TABLEProgressive Electrical Therapeutics1994-09-29450
K940238TUMBLE FORMS JUNIOR TRISTANDERCamp Intl., Inc.1994-03-07470
K932231ECONOMY HI-LOW MAT TABLE #4110 THRU 4117Bailey Mfg. Co.1993-07-22760
K932233ECONOMY HI-LOW WORK TABLE (MANUAL) MODEL 3405Bailey Mfg. Co.1993-07-22760
K932238ECO. HI-LOW TREATMENT TABLES VARIOUS MODEL NUMBERSBailey Mfg. Co.1993-07-22760
K932234PROFESSIONAL & ECONMY TILT TABLE 9500 9520Bailey Mfg. Co.1993-07-22760
K931635TREATMENT TABLES, MANUALLY ACTIVATEDMed Mart, Inc.1993-07-211110
K926026DESKSTheradapt Products, Inc.1993-03-241610
K923751ABLE GENERATION DESKThe Able Generation, Inc.1993-01-291850
K922965TUMBLE FORMS TRISTANDERTumble Forms1992-07-13240
K914769EXTENDO-BAC TABLEReinert Technics, Inc.1992-01-08780
K902466TITAN ZODIAC ADJUSTING TABLETitan Tables1990-06-1170
K902465TITAN HERCULES ADJUSTING TABLETitan Tables1990-06-1170
K901375GRASP (GRIGG-RUSSEL AIR SUPPORT PILLOW)Medical Plastics Laboratory, Inc.1990-04-19280
K895444THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHIONMcvicar Enterprises, Ltd.1989-12-13990
K896256REFLUX BEDCozcon, Inc.1989-11-0880
K895016MODEL #510/515 GENERAL TRANSPORT STRETCHERMidmark Corp.1989-09-11340
K894987MODEL #520/525 ED/RECOVERY STRETCHERMedmark, Inc.1989-09-05280
K892697E653 OBLONG ABDUCTION BLOCKRifton Equipment For the Handicapped1989-05-09260
K892698E655 ADJUSTABLE ABDUCTION BLOCK W/HIP STABILIZERRifton Equipment For the Handicapped1989-05-09260
K892700E65 35 PRONE STANDERRifton Equipment For the Handicapped1989-05-09260
K892699E613 PAIR OF SUPPORT BLOCKSRifton Equipment For the Handicapped1989-05-09260
K882900MECHANICAL TABLES AND ACCESSORIESRifton1988-08-19390
K880222ZENITH TRAVELER CHIROPRACTIC TABLEWilliams Manufacturing Co.1988-02-03140
K862925HEFFINGTON KNEE RESTLex-Ton Orthopedics1986-08-14130
K862894SCHOOLTABLEMednet, Inc.1986-08-13220
K861350R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213Tri W-G, Inc.1986-05-02250
K823149OB TILT TABLEOrthion Corp.1982-11-05160
K811438ACRATRAC RAvratronics Corp.1981-06-09180
K810445MECHANICAL TABLEFred Sammons, Inc.1981-03-04130
K801643TRITONChattanooga Group, Inc.1980-07-28112
K780531MILLER TABLEVictor John Manley1978-04-13140

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