Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2013 — Predicate Candidate Screening
3,052 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
123 daysmedian FDA review time
280 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132629 | REPROCESSED DILATING TIP TROCARS | Stryker Sustainability Solutions | 2013-12-31 | 131 | 0 |
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTA | The Anspach Effort, Inc. | 2013-12-31 | 259 | 0 |
| K133081 | TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, | Advanced Orthopaedic Solutions, Inc. | 2013-12-31 | 92 | 0 |
| K132520 | NASAL EASE ALLERGY BLOCKER | Hi-Tech Pharmacal, Inc. | 2013-12-31 | 141 | 0 |
| K133026 | UNBALLOON NON-OCCLUSION MODELING CATHETER | LeMaitre Vascular, Inc. | 2013-12-31 | 96 | 0 |
| K133806 | M1 CAPNOGRAPHY MASK | Monitor Mask, Inc. | 2013-12-31 | 15 | 0 |
| K132559 | MONUMENT SPACERS | Globus Medical, Inc. | 2013-12-30 | 137 | 0 |
| K133490 | G-SCAN BRIO | Esaote, S.p.A. | 2013-12-30 | 47 | 0 |
| K132867 | SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK AL | Cayenne Medical, Inc. | 2013-12-30 | 108 | 0 |
| K132747 | VISUM BLADE LED SURGICAL LIGHTING SYSTEM | Stryker Communications | 2013-12-30 | 118 | 0 |
| K132308 | CLIQ DV-300 ASPIRATOR | Ding Hwa Co., Ltd. | 2013-12-30 | 158 | 0 |
| K132875 | COMPRESSYN STAPLE | Dallen Medical, Inc. | 2013-12-30 | 108 | 0 |
| K130895 | REUNION RSA SHOULDER SYSTEM | Howmedica Osteonics Corp. | 2013-12-27 | 270 | 0 |
| K131259 | LASER-STIM | Shenzhen Dongdixin Technology Co., Ltd. | 2013-12-27 | 239 | 0 |
| K131050 | NXSTAGE 1.6M2 DIALYZER | Nxstage Medical, Inc. | 2013-12-27 | 256 | 0 |
| K132481 | EASY-LOAD LENS DELIVERY SYSTEM | Bausch & Lomb | 2013-12-27 | 141 | 0 |
| K133505 | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM | Samsung Medison Co., Ltd. | 2013-12-27 | 43 | 0 |
| K132674 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-3 | Becton, Dickinson and Company | 2013-12-27 | 122 | 1 |
| K132007 | STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAIN | Stericycle, Inc. | 2013-12-27 | 179 | 0 |
| K131789 | CEREBRALOGIK- AEEG | Mennen Medical , Ltd. | 2013-12-27 | 192 | 0 |
| K133113 | KINGTECH FOREHEAD THERMOMETER | Kingtech Enterprise, Ltd. | 2013-12-26 | 87 | 0 |
| K130570 | NEUROVISION MEDICAL MOTION SENSOR | Neurovision Medical Products, Inc. | 2013-12-26 | 297 | 0 |
| K133283 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS | Candela Corp. | 2013-12-26 | 62 | 0 |
| K133422 | 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, | Neocoil, LLC | 2013-12-26 | 48 | 0 |
| K132095 | OLEA SPHERE | Olea Medical | 2013-12-26 | 171 | 0 |
| K133111 | KINGTECH DIGITAL THERMOMETER | Kingtech Enterprise, Ltd. | 2013-12-26 | 87 | 0 |
| K130975 | SWABCAP AND SWABFLUSH | Excelsior Medical Corp. | 2013-12-24 | 260 | 2 |
| K132601 | COROENT STERILE IMPLANTS SYSTEM | Nu Vasive, Incorporated | 2013-12-24 | 126 | 0 |
| K130325 | ARM AUTOMATIC BLOOD PRESSURE MONITOR | Shenzhen Pump Medical System Co., Ltd. | 2013-12-24 | 319 | 0 |
| K130977 | SIGNIFY BIOACTIVE | Globus Medical, Inc. | 2013-12-24 | 259 | 0 |
| K131521 | VELOX ANTERIOR CERVICAL PLATE SYSTEM | Spinecraft, LLC | 2013-12-24 | 210 | 0 |
| K132511 | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORIN | Abbott Diabetes Care, Inc. | 2013-12-24 | 134 | 0 |
| K131169 | MOZEC - RX PTCA BALLOON DILATATION CATHETER | Meril Life Sciences Private Limited | 2013-12-24 | 244 | 0 |
| K131724 | PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE | Pioneer Surgical Technology, Inc. | 2013-12-24 | 195 | 0 |
| K133431 | VENUE 50 | GE Healthcare | 2013-12-24 | 46 | 0 |
| K132787 | LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE | Aap Implantate AG | 2013-12-24 | 109 | 0 |
| K130572 | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM | Implant Direct Sybron Manufacturing, LLC | 2013-12-24 | 295 | 0 |
| K131447 | INTUITION - TDA, TVA, PARAMETRIC MAPPING | Terarecon,Inc. | 2013-12-24 | 218 | 0 |
| K131164 | ACUSON | Siemens Medical Solutions USA, Inc. | 2013-12-24 | 244 | 0 |
| K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL S | Immunodiagnostic Systems , Ltd. | 2013-12-24 | 382 | 0 |
| K130519 | PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS | Philips Lighting Company | 2013-12-24 | 300 | 0 |
| K132854 | EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CON | Yung Sheng Optical Co., Ltd. | 2013-12-23 | 102 | 0 |
| K133634 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CAT | Cook, Inc. | 2013-12-23 | 27 | 0 |
| K131821 | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY | Phadia US, Inc. | 2013-12-23 | 186 | 0 |
| K133133 | LAURIMED POLYPVAC MICRODEBRIDER | Laurimed, LLC | 2013-12-23 | 84 | 1 |
| K131901 | IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 | 3B Medical, Inc. | 2013-12-23 | 181 | 0 |
| K132386 | TOTALSHIELD SURGICAL HELMET SYSTEM | Zimmer, Inc. | 2013-12-23 | 144 | 0 |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | CooperVision, Inc. | 2013-12-23 | 27 | 0 |
| K132500 | CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUD | Cure Medical, LLC | 2013-12-23 | 136 | 0 |
| K122932 | SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE W | Fogless International AB | 2013-12-23 | 455 | 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