Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2009 — Predicate Candidate Screening
3,008 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
94 daysmedian FDA review time
253 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093392 | MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS | Navilyst Medical, Inc. | 2009-12-31 | 62 | 3 |
| K091541 | MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES | Sequal Technologies Co., Ltd. | 2009-12-31 | 219 | 0 |
| K082249 | MORPHEUS | Meibach Tech Ltda | 2009-12-31 | 510 | 0 |
| K090920 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 9 | The Binding Site, Ltd. | 2009-12-30 | 273 | 1 |
| K092791 | KNEEHAB XP CONTROLLER, MODEL 411 | Bio-Medical Research, Ltd. | 2009-12-30 | 110 | 0 |
| K092087 | MEDTRONIC DENTAL TCP | Medtronic Sofamor Danek USA, Inc. | 2009-12-30 | 174 | 0 |
| K090986 | STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGME | Dfine, Inc. | 2009-12-30 | 267 | 0 |
| K092906 | VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH2 | STERIS Corporation | 2009-12-30 | 100 | 0 |
| K093006 | FONIX ,MODEL 8000 | Frye Electronics, Inc. | 2009-12-30 | 93 | 0 |
| K092174 | ENABLER-P CATHETER SYSTEM, MODEL 3000 | Endocross, Ltd. | 2009-12-30 | 162 | 0 |
| K093139 | BANTAM,48XXXXXX, 50XXXXXX | ClearStream Technologies , Ltd. | 2009-12-30 | 86 | 0 |
| K093141 | MARS HOLTER ANALYSIS WORKSTATION | Ge Medical Systems Information Technologies | 2009-12-29 | 85 | 0 |
| K092855 | MILTEX MEMBRANE TACK KIT | Miltex, Inc. | 2009-12-29 | 104 | 0 |
| K092588 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD- | Andon Health Co, Ltd. | 2009-12-29 | 127 | 0 |
| K091227 | PIEZOSURGERY 3; OSSTEM PIEZO | Piezosurgery S.R.L. | 2009-12-29 | 245 | 0 |
| K093067 | LIPOSE DISPOSABLE CANNULA | Lipose Corp. | 2009-12-29 | 90 | 0 |
| K092929 | SYNTHES MATRIX SYSTEM | Synthes (Usa) | 2009-12-29 | 97 | 1 |
| K091585 | VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M825996 | Kci USA, Inc. | 2009-12-29 | 210 | 0 |
| K093072 | STARCARE HANDPIECE MAINTENANCE UNIT | Dentalez, Inc. | 2009-12-28 | 89 | 0 |
| K092450 | HUMAN IGD KIT FOR USE ON SPAPLUS | The Binding Site | 2009-12-28 | 140 | 0 |
| K092674 | SIMPLER TOADSTOOL MINI IMPLANT | Pan Global Implant | 2009-12-28 | 118 | 0 |
| K091851 | STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED | Gx Corporation Sdn Bhd | 2009-12-28 | 189 | 0 |
| K093037 | PENTEX EC-3890LI | Pentax Medical Company | 2009-12-28 | 90 | 0 |
| K093393 | LIFEDOP MODEL 300ABI | Summit Doppler Systems, Inc. | 2009-12-24 | 55 | 0 |
| K090959 | LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA | D'Antonio Consultants International, Inc. (Dci) | 2009-12-24 | 262 | 0 |
| K093551 | PARADIS VASO SHIELD | Spinemedica, LLC | 2009-12-24 | 37 | 0 |
| K093250 | PROTON THERAPY MULTILEAF COLLIMATOR | Varian Medical Systems | 2009-12-24 | 69 | 0 |
| K093035 | FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244 | Taidoc Technology Corporation | 2009-12-24 | 85 | 0 |
| K093704 | AVS PL PEEK SPACERS | Stryker Corp. | 2009-12-23 | 22 | 0 |
| K093675 | INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 | Vertebral Technologies, Inc. | 2009-12-23 | 26 | 0 |
| K093616 | V. MUELLER CAMERA CONTROLLER WITH STORAGE CART | Carefusion 2200 | 2009-12-23 | 34 | 0 |
| K093613 | VASCUVIEW TAP ULTRASOUND SYSTEM | Escalon Medical Corp. | 2009-12-23 | 30 | 0 |
| K091579 | FORESEE HOME | Notal Vision , Ltd. | 2009-12-23 | 204 | 0 |
| K093391 | SIMUPLAN TREATMENT PLANNING SYSTEM | Simuplan S.L. | 2009-12-23 | 54 | 0 |
| K092510 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD | Andon Health Co, Ltd. | 2009-12-23 | 128 | 0 |
| K092803 | CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT | Cardo Medical Corp. | 2009-12-23 | 103 | 0 |
| K090832 | RAPID-I | Vitrolife Sweden AB | 2009-12-23 | 272 | 0 |
| K090820 | TRIA HAIR REMOVAL LASER SYSTEM | Spectragenics, Inc. | 2009-12-23 | 272 | 0 |
| K091265 | ZOLL E SERIES WITH CPRREADYCHARGE | Zoll Medical Corporation, World Wide Headquarters | 2009-12-23 | 237 | 0 |
| K090690 | VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | 2009-12-23 | 282 | 0 |
| K092469 | O-SCAN MR SYSTEM | Esaote, S.p.A. | 2009-12-23 | 134 | 0 |
| K093242 | PATRIOT TRANSCONTINENTAL LLIF SPACER | Globus Medical, Inc. | 2009-12-23 | 69 | 0 |
| K091644 | SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES | Synthes (Usa) | 2009-12-23 | 202 | 0 |
| K093663 | RADIONUCLIDE BRACHYTHERAPY SOURCE | C.R. Bard, Inc. | 2009-12-23 | 28 | 1 |
| K091426 | CERVICORE CORPECTOMY CAGE | Verticor, Ltd. | 2009-12-23 | 224 | 0 |
| K091749 | U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGUL | Kimberly-Clark Corp. | 2009-12-23 | 190 | 0 |
| K092438 | ZIEHM SOLO | Ziehm Imaging, Inc. | 2009-12-23 | 138 | 3 |
| K092371 | SWIFT-LOCK ANCHOR, MODEL 1192 | Advanced Neuromodulation Systems | 2009-12-23 | 140 | 1 |
| K090555 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, M | Maquet Cardiopulmonary, AG | 2009-12-23 | 296 | 1 |
| K093452 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5 | Andon Health Co, Ltd. | 2009-12-23 | 48 | 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