Atlas FDA

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

FPO — Predicate Candidate Screening

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

63 daysmedian FDA review time
227 days90th percentile
50clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K113598POWER-LOAD COT FASTENER SYSTEMStryker Medical2011-12-20153
K072598IRSG I-MOVER FOR BEDSInternational Retail Services Group, LLC2008-04-142130
K972528DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)Dyna Corp.1997-07-28210
K955766ADULT-PEDIATRIC TRANSPORT SYSTEMInternational Biomedical, Inc.1996-08-072310
K962181HARE MODEL 2000 EZ LOADER MODEL 95555Dyna Corp.1996-08-01560
K961437WHEELED STRETCHERHill-Rom, Inc.1996-06-03490
K952447HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHERHill-Rom, Inc.1995-11-221810
K946101EMERGENCY/ACCIDENT TROLLEY 550Hogan & Hartson1995-02-07550
K945431MODEL 792 CONVERGE, MODEL 793 VISION 2000Hausted, Inc.1995-01-251630
K943969MODEL 578 MOBILE SURGICAL STRETCHERHausted, Inc.1995-01-251630
K942948STRYKER POWERED STRETCHERStryker Corp.1995-01-242150
K943528PATIENT TROLLEY 545Merivaara Instrumentarium Corp.1994-10-04750
K943529PATIENT TROLLEY 540Merivaara Instrumentarium Corp.1994-10-04750
K943262FUTURA JUNIOR 300/310Merivaara Instrumentarium Corp.1994-09-29840
K943864STRYKER 8000 SURGERY STRETCHERStryker Medical1994-08-25170
K935297STRYKER AMBULANCE COT MODEL 6060Stryker Medical1994-02-181080
K923730MODEL 561 C-ARM PROCEDURES STRETCHERMidmark Corp.1994-02-095620
K933060S-610 & 2-628 WHEELED SHOWER STRETCHERSThe Anthros Medical Group1994-02-042270
K933071STS 701 TRANSPORT STRETCHERWy'East Medical Corp.1994-01-262180
K933366I.V. LINKDeville Laboratories, Inc.1994-01-101850
K932260FERNO-WASHINGTON AMBULANCE COT, 93ES SQUAD-MATEFerno1993-09-091420
K922808HILL-ROM VIA STRETCHER (P1300 - P1303)Hill-Rom, Inc.1993-03-312940
K922809GENERAL PROCEDURAL STRETCHERS (P880- P886)Hill-Rom, Inc.1993-03-312940
K920704STRYKER I.V. CADDY ACCESSORY DEVICEStryker Medical1992-03-23340
K914543ST5500 UNIVERSAL CARE STRETCHERLic Care, Inc.1992-01-08900
K904011MODEL #527 OPHTHALMIC STRETCHERMidmark Corp.1990-10-03350
K902503HARE FOLDING BACK EMERGENCY STRETCHERDyna Corp.1990-06-26210
K900872WHEELED STRETCHERHospital Supply Co., Inc.1990-05-18810
K895740SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CARTLumex, Inc.1990-02-221490
K884759SHOWER STRETCHER W/WHEELSLinido, Inc.1989-06-152130
K881845HARE ANY LEVEL COTDyna Industries, Inc.1988-06-03320
K874332MRI STRETCHERAtomic Products Corp.1988-01-05750
K873181STRETCHER, WHEELED, MECHANICALCambridge Technologies, Inc.1987-10-09580
K871556MERIVAARA EMERGENCY PATIENT TROLLEY #436Global Medical Prods, Inc.1987-04-3080
K864269MODEL 35-B ALL LEVEL COTFerno-Washington, Inc.1986-11-13150
K862959MERIVAARA PATIENT TROLLEY - MODEL #416Global Medical Prods, Inc.1986-09-25510
K862441EZ LOAD MODEL 30, ALL LEVEL COTFerno-Washington, Inc.1986-09-12782
K863083BETA MEDICAL PRODUCTS EMR-301 HYDRAULIC STRETCHERBeta Medical Products Co.1986-09-03220
K861410LIC MOBILE TRANSPORT STRETCHERSLada Intl., Inc.1986-04-2270
K854304KEYMED OFFICE COUCHKeymed, Inc.1985-11-12180
K853421THE KEYMED VARI-HEIGHT PATIENT COUCHKeymed, Inc.1985-09-19360
K844578NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONAEngineering Dynamics Corp.1985-05-141720
K843439CENTURIAN HYDRAULIC STRETCHERAmerican Sterilizer Co.1984-09-1390
K840920KEYMED MOBILE ENDOSCOPY PATIENT COUCHKeymed, Inc.1984-03-19180
K840124IURA UNIVERSAL HOSPITAL STRETCHER-HS-13Trade West, Inc.1984-01-27160
K840122IURA AMBULANCE STRETCHER IAS-1Trade West, Inc.1984-01-27160
K840125IURA UNIVERSAL WHEELCHAIR/STRETCHER-Trade West, Inc.1984-01-27160
K801935PAD, HOSPITAL STRETCHERVolunteer Blind Industries, Inc.1980-08-27150
K792570PATIENT TROLLEY B49Ets Rene Marzet1979-12-31180
K761147RELIANCE MOD-U-LINE M-700F. & F. Koenigkramer1977-01-28630

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