Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2003 — Predicate Candidate Screening
3,516 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
71 daysmedian FDA review time
208 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032554 | GEN-PROBE APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2003-12-31 | 134 | 0 |
| K033671 | GORE BIOABSORBABLE MESH | W. L. Gore & Associates, Inc. | 2003-12-31 | 37 | 0 |
| K033242 | KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) | Imaging Therapeutics, Inc. | 2003-12-31 | 85 | 0 |
| K033804 | BIOANCHOR WITH DISPOSABLE DRIVER | Linvatec Corp. | 2003-12-31 | 23 | 1 |
| K033636 | AMS LARGE PORE POLYPROPYLENE MESH | American Medical Systems, Inc. | 2003-12-31 | 42 | 0 |
| K033339 | ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY | Varian Medical Systems, Inc. | 2003-12-30 | 74 | 3 |
| K033778 | MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT | C.R. Bard, Inc. | 2003-12-30 | 26 | 0 |
| K033754 | TRACER METRO SMART WIRE GUIDE | Wilson-Cook Medical, Inc. | 2003-12-30 | 29 | 0 |
| K033794 | ULTICARE DISPOSABLE SYRINGE 3 ML/CC | Ultimed, Inc. | 2003-12-30 | 25 | 0 |
| K033317 | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM- | Opus Medical, Inc. | 2003-12-30 | 76 | 0 |
| K033356 | VERASOFT ES | Aalba Dent, Inc. | 2003-12-30 | 101 | 0 |
| K033256 | ATHENA PELVIC MUSCLE TRAINER II | Athena Feminine Technologies, Inc. | 2003-12-30 | 82 | 0 |
| K033412 | MEDICLUNG, RELEASE 1 | Medicsight | 2003-12-30 | 64 | 0 |
| K033916 | GRI-BAG, GRI-BAG AP | Laboratorios Grifols, S.A. | 2003-12-30 | 12 | 1 |
| K033781 | BEBIG ISOSEED I-125 | Bebig Isotopen-Und Medizintechnik GmbH | 2003-12-30 | 26 | 0 |
| K033147 | CLEARTOOTH DIGITAL X-RAY SYSTEM | Cleartooth Electronics, Inc. | 2003-12-30 | 91 | 0 |
| K033836 | HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2003-12-30 | 20 | 0 |
| K033665 | VENUS FLOW | Heraeus Kulzer, Inc. | 2003-12-30 | 39 | 0 |
| K032127 | HEMEDEX FIXATION DEVICE | Hemedex Incorporated | 2003-12-30 | 173 | 0 |
| K033250 | EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH TH | Edwards Lifesciences, LLC | 2003-12-30 | 84 | 0 |
| K033874 | MYOLIGHT | Ge Medical Systems F.I. Haifa | 2003-12-30 | 15 | 0 |
| K033038 | GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOAS | Beckman Coulter, Inc. | 2003-12-29 | 91 | 1 |
| K033478 | VACUETTE QUICKSHIELD SAFETY TUBE HOLDER | Greiner Bio-One Vacuette North America | 2003-12-29 | 56 | 0 |
| K033829 | BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2 | Bruno Independent Living Aids, Inc. | 2003-12-29 | 20 | 0 |
| K032194 | TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLE | Gen-Probe, Inc. | 2003-12-24 | 159 | 0 |
| K031869 | SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INST | Surgical Instruments Service and Savings, Inc. | 2003-12-24 | 190 | 0 |
| K032571 | IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBOD | Immco Diagnostics, Inc. | 2003-12-24 | 126 | 0 |
| K033371 | VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS | Varian Medical Systems | 2003-12-24 | 64 | 2 |
| K033906 | PORTASCAN BLADDER SCANNER, MODEL PA00146 | Mediwatch Plc | 2003-12-24 | 7 | 0 |
| K033001 | APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL- | Transphoton Corporation | 2003-12-24 | 90 | 0 |
| K033487 | STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI | Dade Behring, Inc. | 2003-12-24 | 50 | 1 |
| K031267 | STERICHEK BICARB PH REAGENT STRIPS | Environmental Test Systems, Inc. | 2003-12-23 | 246 | 0 |
| K032563 | CLINITEST HCG PREGNANCY TEST | Bayer Healthcare, LLC | 2003-12-23 | 125 | 2 |
| K033695 | IRRIGATION CHANNEL TUBING, MODEL 100135 | Byrne Medical, Inc. | 2003-12-23 | 28 | 0 |
| K032113 | ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | Chroma Vision Medical Systems, Inc. | 2003-12-23 | 167 | 0 |
| K033045 | DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, | American Green Dent. Mfg, Inc. | 2003-12-23 | 85 | 0 |
| K031281 | ERGO SRS | 3D Line USA, Inc. | 2003-12-23 | 245 | 0 |
| K033832 | SYNGO PERFUSION-CT | Siemens AG Medical Solutions | 2003-12-23 | 13 | 0 |
| K033847 | A1CNOW FOR HOME AND PROFESSIONAL USE | Metrika, Inc. | 2003-12-23 | 12 | 0 |
| K033113 | UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSIST | Richard Wolf Medical Instruments Corp. | 2003-12-23 | 84 | 0 |
| K033023 | INTERMITTENT URETHRAL CATHETERS | Rusch Intl. | 2003-12-23 | 88 | 0 |
| K033360 | DIAZYME LITHIUM ENZYMATIC ASSAY KIT | General Atomics | 2003-12-23 | 63 | 0 |
| K033541 | LONG LOVE CONDOM | Unidus Corp. | 2003-12-23 | 43 | 0 |
| K033046 | SUBTALAR PEG IMPLANT | Nexa Orthopedics, Inc. | 2003-12-23 | 85 | 0 |
| K032417 | HEPARIN LOCK FLUSH SYRINGE | Am2 Pat, Inc. | 2003-12-23 | 140 | 1 |
| K033383 | TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, | Biosite Incorporated | 2003-12-23 | 61 | 0 |
| K033712 | MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION | Sectra-Imtec AB | 2003-12-23 | 27 | 0 |
| K031322 | INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS | Intra-Lock International | 2003-12-23 | 242 | 0 |
| K030360 | RANDOX EVIDENCE | Randox Laboratories, Ltd. | 2003-12-23 | 323 | 0 |
| K031689 | DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) | Chf Solutions, Inc. | 2003-12-23 | 204 | 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