Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
2007 — Predicate Candidate Screening
2,987 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
84 daysmedian FDA review time
234 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070789 | EUROIMMUN ANTI-CCP ELISA | Euroimmun Us, LLC | 2007-12-31 | 284 | 0 |
| K071695 | KENSEY NASH MACROPORE SHIELD | Kensey Nash Corp. | 2007-12-31 | 194 | 0 |
| K072718 | PENUMBRA SYSTEM | Penumbra, Inc. | 2007-12-28 | 94 | 1 |
| K070857 | NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM | Nobel Biocare AB | 2007-12-28 | 275 | 0 |
| K071671 | SCANSCOPE XT SYSTEM | Aperio Technologies | 2007-12-28 | 192 | 0 |
| K071905 | POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | Lanx, LLC | 2007-12-28 | 171 | 0 |
| K073378 | ADVANCE 18LP PTA DILATATION CATHETER | Cook, Inc. | 2007-12-28 | 25 | 0 |
| K072528 | ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE | Prosurg, Inc. | 2007-12-28 | 112 | 0 |
| K072105 | ALARIS SYSTEM WITH MMS, MODEL 8XXX | Cardinal Health 303,Inc. | 2007-12-28 | 150 | 5 |
| K072937 | OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD | Olsen Medical | 2007-12-28 | 73 | 0 |
| K072570 | NOBELACTIVE MULTI UNIT ABUTMENT | Nobel Biocare AB | 2007-12-28 | 107 | 1 |
| K072813 | EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) | Phasein AB | 2007-12-28 | 88 | 0 |
| K063716 | AEROSOL SYSTEM | Amici, Inc. | 2007-12-28 | 379 | 0 |
| K073221 | CADENCE II | Edan Instruments, Inc. | 2007-12-28 | 43 | 0 |
| K073436 | SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM | Lutronic Corporation | 2007-12-28 | 22 | 0 |
| K070357 | FLEXCATH STEERABLE SHEATH & DILATOR | Cryocath Technologies, Inc. | 2007-12-28 | 324 | 0 |
| K072485 | ARTISTE MV SA | Siemens Medical Solutions USA, Inc. | 2007-12-27 | 114 | 20 |
| K072484 | CYNOSURE YAG FAMILY LASER | Cynosure, Inc. | 2007-12-27 | 114 | 0 |
| K072996 | REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM | Respironics, Inc. | 2007-12-27 | 64 | 1 |
| K073367 | HEMOSIL FIBRINOGEN-C | Instrumentation Laboratory CO | 2007-12-27 | 27 | 0 |
| K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | R&D Systems, Inc. | 2007-12-27 | 44 | 0 |
| K073237 | REHASTIM & REHAMOVE | Hasomed GmbH | 2007-12-27 | 41 | 0 |
| K072836 | CHOLESTRAK HDL CHOLESTEROL HOME TEST | Accutech, LLC | 2007-12-27 | 85 | 0 |
| K071886 | SELF SEAL STERILIZATION POUCH | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2007-12-27 | 171 | 0 |
| K070012 | POLYBONE | Kyung Won Medical Co., Ltd. | 2007-12-27 | 358 | 0 |
| K072159 | SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER | El.En Electronic Engineering Spa | 2007-12-27 | 143 | 0 |
| K073348 | LUCENT MAGNUM | Spinal Elements, Inc. | 2007-12-26 | 27 | 0 |
| K073066 | 308 DERMATOLOGICAL EXCIMER SYSTEM | Quantel Medical, Inc. | 2007-12-26 | 57 | 0 |
| K072788 | STORZ MODULITH LITHOTRIPTER SLX-F2-F180 | KARL STORZ Endoscopy-America, Inc. | 2007-12-26 | 86 | 0 |
| K072979 | SPIROBANK G | Mir Medical Intl. Research Srl | 2007-12-26 | 65 | 0 |
| K072261 | FINESSE SYSTEM | Primaeva Medical, Inc. | 2007-12-26 | 134 | 0 |
| K072231 | THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 P | Esm Technologies, LLC | 2007-12-26 | 138 | 0 |
| K072791 | ORACLE SPACER, OPAL SPACER | Synthes Spine | 2007-12-26 | 86 | 0 |
| K072407 | BODYFORM THORACIC FIXATION SYSTEM | Theken Spine, LLC | 2007-12-21 | 116 | 0 |
| K072068 | BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAU | Bioartificial Gel Technologies (Bagtech), Inc. | 2007-12-21 | 147 | 0 |
| K072328 | MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT | Medtrade Products , Ltd. | 2007-12-21 | 123 | 0 |
| K073199 | 3M ESPE LAVA CHAIRSIDE ORAL SCANNER | Brontes Technologies | 2007-12-21 | 38 | 0 |
| K073399 | TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE | Envisioneering, LLC | 2007-12-21 | 17 | 0 |
| K071375 | MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) | Disc-O-Tech Medical Technologies, Ltd. | 2007-12-21 | 219 | 0 |
| K072475 | BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP | Etac Sverige AB | 2007-12-21 | 108 | 0 |
| K072640 | IRISPEC,CA/CB/CC | Iris Diagnostics | 2007-12-21 | 94 | 2 |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | Dade Behring, Inc. | 2007-12-21 | 60 | 0 |
| K072138 | VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 | bioMerieux, Inc. | 2007-12-21 | 141 | 0 |
| K072886 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T | Medrad, Inc. | 2007-12-21 | 73 | 0 |
| K043617 | IMAGECHECKER CT CAD SOFTWARE SYSTEM | Hologic, Inc. | 2007-12-21 | 25 | 0 |
| K062580 | GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1 | GE Healthcare | 2007-12-21 | 477 | 0 |
| K072784 | PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4 | Taidoc Technology Corporation | 2007-12-21 | 81 | 0 |
| K070458 | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 | Biomedical Diagnostics (Bmd) SA | 2007-12-21 | 308 | 0 |
| K063304 | LIFE4C | Numedis, Inc. | 2007-12-21 | 415 | 0 |
| K070486 | CAPILLARYS URINE (PN 2012) | Sebia, Inc. | 2007-12-21 | 304 | 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