Guide
The most-cited predicate devices
59,769 devices in FDA’s records have been cited as a predicate by at least one later device; 1,140 by ten or more, and 9 by fifty or more. The most cited is K020321, BD Phoenix Automated Microbiology System (Becton, Dickinson & CO, 2002), named as a predicate by 103 later devices.
Figures from FDA decisions to Oct 23, 2026 recomputed weekly, last Nov 3, 2026
Cited at least once
59,769
devices
Cited 10+ times
1,140
devices
Cited 50+ times
9
devices
Citations, last 12 months
4,462
to Oct 23, 2026
Cited most, all time
A heavily cited device is a comparison FDA has accepted many times. It anchors a family of later devices, and anything wrong with it reaches them too.
- K020321BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 2002103cite it
- P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsDepuy Spine, Inc. · 199999cite it
- K020322BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 200294cite it
- K020323BD Phoenix Automated Microbiology SystemBecton, Dickinson & CO · 200291cite it
- K032908Fuguan (Brand) Powder-Free Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 200375cite it
- K000684Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 200069cite it
- K021932Synthes 6.5 MM Cannulated ScrewSynthes (Usa) · 200262cite it
- P980048Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 200154cite it
- K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 200951cite it
- K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc. · 201449cite it
- K171422Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink ColorEver Global (Vietnam) Enterprise Corp · 201845cite it
- K011335Synths One-Third Tubular DCL PlateSynthes (Usa) · 200143cite it
- K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSynthes (Usa) · 200843cite it
- K030866Synthes Anterior CSLP SystemSynthes (Usa) · 200342cite it
- K071795Nuvasive Coroent SystemNuvasive, Inc. · 200742cite it
- K031585U&I, Optima, Spinal SystemU&I Corp., America · 200341cite it
- K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 200841cite it
- K063049Synthes (Usa) Modular Mini Fragment LCP SystemSynthes (Usa) · 200640cite it
- K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. · 201640cite it
- K000536Synthes Anterior CSLP SystemSynthes Spine · 200040cite it
Cited most in the last twelve months
Among the 4,462 predicate citations in 510(k)s decided in the twelve months to Oct 23, 2026.
- K230052Inogen Rove 6Inogen, Inc. · 20236citations
- K191243HEDRON Cervical SpacersGlobus Medical, Inc. · 20196citations
- K241322Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)Joytech Healthcare Co., Ltd. · 20246citations
- K051218Modification to: Unicap Specific IgePharmacia Diagnostics AB · 20056citations
- K241846E3D™-C Interbody SystemEvolution Spine · 20245citations
- K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM)…Medtronic Sofamor Danek · 20165citations
- K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O · 20225citations
- K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 20235citations
- K223494CD Horizon Spinal SystemMedtronic · 20235citations
- K242850Wearable breast pump (model W8)Shenzhen TPH Technology Co., Ltd. · 20254citations
Find the right predicate for your device. A 510(k) Report ranks candidate predicates for your device concept by fit, citations and recall history, with the review-time outlook for its product code. $995, emailed as a PDF, usually within a few hours.
The widest family trees
Descendants count every later device that reaches this one through predicates, at any number of steps.
- K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 19842,425descendants
- K001340Stackable Cage SystemDepuyacromed · 20002,423descendants
- K003155Vertebral Body ReplacementOsteotech, Inc. · 20012,091descendants
- K012254VBROsteotech, Inc. · 20012,058descendants
- K010930Lift VB Spinal SystemMedtronic Sofamor Danek, Inc. · 20012,053descendants
- K011406Spinal Mesh SystemMedtronic Sofamor Danek, Inc. · 20012,048descendants
- K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek · 20022,047descendants
- K990148Stackable Cage SystemDepuy Motech Acromed · 19991,867descendants
- K003043Surgical Titanium Mesh SystemDepuyacromed · 20011,819descendants
- K010530Geo StructureInterpore Cross Intl. · 20011,764descendants
The most-cited predicate in each review panel
| Review panel | Device | Cited by |
|---|---|---|
| Anesthesiology | K061901 Ino Therapeutics Inomax DS (Delivery System), Model 10003 Ino Therapeutics, 2006 | 14 |
| Cardiovascular | K032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90… Philips Medizin Systeme Boblingen GmbH, 2003 | 37 |
| Clinical chemistry | K951595 Roche Cobas Integra Analyzer, Reagent Cassettes Roche Diagnostic Systems, Inc., 1995 | 32 |
| Clinical toxicology | K052115 First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine… First Check Diagnostics, LLC, 2005 | 13 |
| Dental | K062129 P.0004 Implants Institut Straumann AG, 2006 | 31 |
| Ear, nose and throat | K173727 Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim… Ambu A/S, 2018 | 16 |
| Gastroenterology and urology | K131861 DA Vinci Surgical System, Endowrist Instruments and… Intuitive Surgical, Inc., 2014 | 32 |
| General and plastic surgery | K153496 Disposable Surgical Face Mask Xiantao Rayxin Medical Products Co., Ltd., 2016 | 40 |
| General hospital | K032908 Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves Shijiazhuang Fuguan Plastic Products Co., Ltd., 2003 | 75 |
| Hematology | K002400 Modification of Acl Advance Instrumentation Laboratory CO, 2000 | 14 |
| Immunology | K051218 Modification to: Unicap Specific Ige Pharmacia Diagnostics AB, 2005 | 27 |
| Microbiology | K020321 BD Phoenix Automated Microbiology System Becton, Dickinson & CO, 2002 | 103 |
| Neurology | K140454 Navigated CD Horizon Solera Screwdriver/Taps Medtronic Sofamor Danek USA, Inc., 2014 | 49 |
| Obstetrics and gynecology | K955648 K-Y Personal Lubricant Ortho Pharmaceutical Corp., 1996 | 15 |
| Ophthalmic | K052560 Biofinity (Comfilcon a) Soft Contact Lens CooperVision, Inc., 2005 | 15 |
| Orthopedic | P960025 Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and… Depuy Spine, Inc., 1999 | 99 |
| Pathology | DEN160056 Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V., 2017 | 9 |
| Physical medicine | K182668 Rapid Reboot Compression Therapy System Rapid Reboot Recovery Products, LLC, 2018 | 16 |
| Radiology | K953946 Microselectron-HDR Version 2 Nucletron-Oldelft Corp., 1996 | 28 |
Doing this for your own device? A 510(k) Report starts from your device concept: it finds the product code and pathway, ranks candidate predicates side by side, and weighs their family trees’ recall history and review times. $995, emailed as a PDF, usually within a few hours.
How these figures are computed
Citations are the predicates named in 510(k) summaries, read from every summary FDA posts and checked against FDA’s records (how). A device cited by two submissions counts two citations. Reference devices, cited for a single test or feature, are not counted. The figures are recomputed from FDA’s records every week; see the methodology.