Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DSA — Predicate Candidate Screening
105 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
264 days90th percentile
105clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254114 | Baylis Connector Cable | Baylis Medical Technologies, Inc. | 2026-01-18 | 30 | 0 |
| K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (260 | Drägerwerk AG & Co. KGaA | 2025-12-01 | 87 | 0 |
| K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP trans | Shanghai Draeger Medical Instrument Co., Ltd. | 2025-09-30 | 123 | 0 |
| K242986 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | 2025-05-02 | 218 | 0 |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Numb | Philips Medizin Systeme Böblingen GmbH | 2025-01-17 | 63 | 0 |
| K240087 | RT Carbon ECG Leads | Ivy Biomedical Systems, Inc. | 2024-09-13 | 246 | 0 |
| K240377 | LIFEPAK® ECG Cables | Stryker Physio-Control | 2024-05-07 | 90 | 1 |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with IC | Physio-Control, Inc. | 2024-04-30 | 102 | 0 |
| K222712 | Fogg System Patient Monitoring Cables | Fogg System Company, Inc. | 2023-11-22 | 440 | 0 |
| K230571 | RFP-100A Connector Cable (Single Use) | Baylis Medical Technologies, Inc. | 2023-05-30 | 90 | 0 |
| K222370 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | 2023-04-02 | 240 | 0 |
| K220447 | Med-link Disposable ECG Cable and Leadwires | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2022-06-28 | 132 | 0 |
| K211941 | 9Line | Energetic Designs, Inc. | 2022-01-27 | 218 | 0 |
| K211294 | Multi-Link X2 ECG Cable and Leadwire System | Vyaire Medical, Inc. | 2021-08-16 | 110 | 0 |
| K203556 | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables | Medtronic, Inc. | 2021-07-12 | 217 | 0 |
| K200722 | PCA-C1 series Patient Cable | QT Medical, Inc. | 2021-06-03 | 441 | 0 |
| K203635 | Patient Monitoring Cables | Jkh USA, LLC | 2021-02-05 | 53 | 0 |
| K200510 | Multi-LinkTM X2 ECG Adapter and Leadwires | Vyaire Medical, Inc. | 2020-10-09 | 221 | 0 |
| K201359 | ECG Cables and Leadwires | Xinkang Medical Instrument Co. , Ltd. | 2020-10-01 | 133 | 0 |
| K200674 | AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp | Atrility Medical, LLC | 2020-07-02 | 108 | 0 |
| K192404 | Patient Monitoring Cable (SpO2 Extension Cable) | Shenzhen Coreray Technology, Ltd. | 2020-06-22 | 293 | 0 |
| K200026 | Disposable ECG Cable | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-05-12 | 127 | 0 |
| K181089 | SureLead Cable System | Authentic Medical | 2020-01-17 | 632 | 0 |
| K191428 | ECG Cable | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-11-27 | 182 | 0 |
| K191273 | Multi-Link X2 ECG and SpO2 Adapter | Vyaire Medical, Inc. | 2019-09-13 | 123 | 0 |
| K190078 | IntraSight | Volcano Corporation | 2019-02-11 | 26 | 0 |
| K182327 | Patient Cables and Leadwires , Disposable ECG Leadwires | Orantech, Inc. | 2019-01-30 | 156 | 0 |
| K182220 | Curbell branded Patient Monitoring Cables | Curbell Medical Products, Inc. | 2018-11-07 | 84 | 0 |
| K181726 | Medline Patient Cables and Lead Wires | Medline Industries, Inc. | 2018-09-20 | 83 | 0 |
| K172797 | ECG Cable/Leadwires | Shenzhen Coreray Technology, Ltd. | 2018-02-28 | 166 | 0 |
| K172591 | Fixed Patient Leads ECG Cable (Model 3153) | Boston Scientific Corporation | 2017-11-03 | 66 | 0 |
| K162768 | ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, | Integral Process Sas | 2017-08-16 | 320 | 0 |
| K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire Syste | Carefusion 303, Inc. | 2017-06-22 | 211 | 0 |
| K170536 | ECG Disposable Lead Wire | APK Technology Co., Ltd. | 2017-04-24 | 60 | 0 |
| K162432 | Multi-Link X2 ECG Cable and Lead Wire System | Carefusion 2200, Inc. | 2017-01-18 | 140 | 0 |
| K153188 | Caremed patient cable and leadwires | Shenzhen Caremed Medical Technology Co., Ltd. | 2016-10-24 | 356 | 0 |
| K152947 | Disposable Temporary Pacing Cable | Tiger Medical Products | 2016-04-05 | 182 | 0 |
| K142489 | Unimed Disposable ECG lead wires | Unimed Medical Supplies, Inc. | 2014-11-04 | 61 | 0 |
| K132253 | REMOVABLE PATIENT LEADS ECG CABLE | Boston Scientific | 2013-12-16 | 150 | 0 |
| K120010 | CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2012-01-19 | 16 | 0 |
| K110287 | PHILIPS ECG LEADWIRE SET | Philips Medical Systems | 2011-02-15 | 15 | 0 |
| K102430 | TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET | Tyco Electronics Corporation | 2010-09-10 | 15 | 0 |
| K101660 | ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 20 | Kepler Medtec | 2010-08-11 | 58 | 0 |
| K093858 | PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL | St. Jude Medical, Cardiac Rhythm Management Divisi | 2010-04-02 | 107 | 0 |
| K093657 | ADAGIO RETRACTING ECG LEAD WIRES | Acist Medical Systems, Inc. | 2010-01-15 | 51 | 0 |
| K082851 | MULTLINK CABLE AND LEADWIRE SYSTEM | Ge Medical Systems Information Technologies | 2008-11-19 | 51 | 0 |
| K082959 | PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESS | Unimed Medical Supplies, Inc. | 2008-10-10 | 7 | 0 |
| K081762 | CURBELL PATIENT MONITORING CABLES | Curbell Electronics, Inc. | 2008-08-27 | 68 | 0 |
| K080112 | PATIENT CABLE | Med-Dyne | 2008-06-20 | 156 | 0 |
| K080605 | SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL | Curbell Electronics, Inc. | 2008-05-05 | 62 | 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