Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2008 — Predicate Candidate Screening
3,053 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
88 daysmedian FDA review time
247 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080740 | CLEARVIEW ENDOSCOPE COVER | Invotec International, Inc. | 2008-12-31 | 289 | 0 |
| K080455 | RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, | Quantrx Biomedical Corporation | 2008-12-31 | 315 | 0 |
| K083452 | ERBE MODEL VIO 300 D WITH ACCESSORIES | Erbe USA, Inc. | 2008-12-31 | 40 | 0 |
| K082203 | NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;C | Ncontact Surgical, Inc. | 2008-12-30 | 147 | 0 |
| K082472 | VIROCULT, MODEL MW950 | Medical Wire & Equipment Company (Bath), Ltd. | 2008-12-30 | 124 | 0 |
| K072964 | NICOLET CORTICAL STIMULATOR | Cardinal Health, Inc. | 2008-12-30 | 438 | 3 |
| K082652 | BITTAR ZIRCONIA BLOCKS | Bittar Zirconia Block, LLC | 2008-12-30 | 109 | 0 |
| K083673 | CARESTREAM PACS, MODEL CARESTREAM PACS VII | Carestream Health, Inc. | 2008-12-30 | 19 | 0 |
| K082878 | NEVONI CLASSIC, MODEL 6600-PO | Nsr Comercio E Representacoes Ltda | 2008-12-30 | 92 | 0 |
| K083213 | SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES | Synthes (Usa) | 2008-12-30 | 60 | 0 |
| K082435 | AMSCO EVOLUTION MEDIUM STEAM STERILIZER | STERIS Corporation | 2008-12-30 | 130 | 2 |
| K083765 | MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL | Medegen Medical Manufacturing Services | 2008-12-30 | 12 | 0 |
| K082999 | ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX C | Arthrex, Inc. | 2008-12-30 | 83 | 0 |
| K082613 | MERIT MICROCATHETER | Merit Medical Systems, Inc. | 2008-12-30 | 113 | 2 |
| K083355 | WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 9 | Blairex Laboratories, Inc. | 2008-12-29 | 46 | 0 |
| K081962 | LAPEX BCS | Meridian Co., Ltd. | 2008-12-29 | 173 | 0 |
| K082709 | VICOR PD2I ANALYZER, VERSION 2.1 | Vicor Technologies, Inc. | 2008-12-29 | 104 | 0 |
| K082946 | MORTARA ELI 350 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2008-12-29 | 88 | 0 |
| K083542 | FRESENIUS STERILE STAY SAFE CAP | Fresenius Medical Care North America | 2008-12-29 | 31 | 1 |
| K083210 | CORFLO ANTI IV ENTERAL FEEDING TUBE | Corpak Medsystems | 2008-12-29 | 59 | 0 |
| K082792 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL | Medacta International S.A. | 2008-12-29 | 97 | 1 |
| K083050 | EVITE XL | Draeger Medical AG & Co. KG | 2008-12-29 | 76 | 0 |
| K083591 | IKOENGELO, VERSION 2 | Ikoetech, LLC | 2008-12-29 | 25 | 0 |
| K083026 | CLYDESDALE SPINAL SYSTEM | Medtronic Sofamor Danek | 2008-12-29 | 80 | 0 |
| K082892 | REJUVENATE MONOLITHIC HIP SYSTEM | Howmedica Osteonics Corp. | 2008-12-29 | 90 | 0 |
| K082010 | STRYKER DISPOSABLE CRANIAL PERFORATOR BIT | Stryker Ireland Ltd., Instruments Division | 2008-12-29 | 167 | 1 |
| K083232 | MODIFICATION TO:MICROFUSE BONE VOID FILLER | Globus Medical, Inc. | 2008-12-24 | 51 | 0 |
| K081060 | FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES ( | Core Essence Orthopaedics, LLC | 2008-12-24 | 254 | 0 |
| K083572 | BD BACTEC Plus Aerobic/F Culture Vials | Becton, Dickinson & CO | 2008-12-24 | 21 | 0 |
| K083347 | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | Fluke Biomedical | 2008-12-24 | 41 | 0 |
| K083091 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | Biocompatibles UK Limited | 2008-12-24 | 68 | 0 |
| K082020 | ENVISION BLOOD GLUCOSE TEST SYSTEM | Infopia Co, Ltd. | 2008-12-24 | 161 | 0 |
| K083271 | BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY | Nihon Kohden America, Inc. | 2008-12-24 | 48 | 0 |
| K083657 | CONQUEST PTA BALLOON DILATATION CATHETER | C.R. Bard, Inc. | 2008-12-24 | 14 | 1 |
| K081551 | TWIN NEUROTRAC-III | Astro-Med, Inc. | 2008-12-24 | 204 | 0 |
| K082909 | RSVP HALF SPHERE PHANTOM, MODEL DDP010 | The Phantom Laboratory, Inc. | 2008-12-23 | 84 | 0 |
| K083249 | QUICKIE RHYTHM | Sunrise Medical Hhg, Inc. | 2008-12-23 | 49 | 0 |
| K083434 | TT1 GENERAL PURPOSE COIL | Tursiop Technologies, LLC | 2008-12-23 | 33 | 0 |
| K083049 | TORNADO ROTATABEL SNARE AND POLYP CATCHER | Horizons Intl. Corp. | 2008-12-23 | 70 | 0 |
| K081173 | ENDOSCOPIC CO2 REGULATION UNIT UCR | Olympus Medical Systems Corporation | 2008-12-23 | 243 | 0 |
| K081928 | D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT | Diagnostic Hybrids, Inc. | 2008-12-23 | 169 | 0 |
| K083344 | HELIODENT PLUS | Sirona Dental Systems GmbH | 2008-12-23 | 40 | 0 |
| K083348 | IMAGE-ARENA APPLICATIONS | Tomtec Imaging Systems GmbH | 2008-12-23 | 40 | 0 |
| K081971 | BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINAT | Nitritex (M) Sdn. Bhd. | 2008-12-23 | 166 | 0 |
| K083613 | QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY | Quanta System Spa | 2008-12-23 | 15 | 0 |
| K083576 | MISER CONTRAST MANAGEMENT SYSTEM | Merit Medical Systems, Inc. | 2008-12-23 | 20 | 0 |
| K082818 | SUBCUTANEOUS NEEDLE INFUSION SET | Marcal Medical, Inc. | 2008-12-23 | 89 | 0 |
| K081768 | COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTIC | Cook Incorporated | 2008-12-23 | 186 | 0 |
| K082677 | AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH IN | American Medical Systems, Inc. | 2008-12-23 | 99 | 1 |
| K080766 | VIDAS RUB IGG | bioMerieux, Inc. | 2008-12-23 | 280 | 0 |
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