510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K893911 | Med-Tech Radiolucent Head Fixation System | Medical Equipment Development Co., Inc. | HBL | Class II | |
| K893823 | Harcros Examination Gloves | H&C Rubber Products Sdn. Bhd. | LYY | Class I | |
| K892978 | Tiger Patient Exam Gloves | Daesung America Co., Inc. | LYY | Class I | |
| K894526 | Fpr Phenobarbital Calibrator Kit | Colony Laboratories, Inc. | DLJ | Class II | |
| K894525 | Fpr Phenobarbital Kit | Colony Laboratories, Inc. | LGQ | Class II | |
| K894520 | Fpr Carbamazepine Calibrator Kit | Colony Laboratories, Inc. | DLJ | Class II | |
| K894519 | Fpr Carbamazepine Kit | Colony Laboratories, Inc. | KLT | Class II | |
| K894464 | Abuscreen Positive Reference Controls | Roche Diagnostic Systems, Inc. | LAS | Class I | |
| K894287 | Uric Acid Test Item Number 65422 | Em Diagnostic Systems, Inc. | KNK | Class I | |
| K894230 | Patient Data Management System (Project 735) | Siemens Medical Laboratories, Inc. | IYE | Class II | |
| K894207 | Ck-Mb/ld-1 Control System | Boehringer Mannheim Corp. | JJT | Class I | |
| K894144 | Power Examination Table Model # 405 | Midmark Corp | LGX | Class I | |
| K894134 | Power Examination Table Model # 411 | Midmark Corp | LGX | Class I | |
| K894123 | Vericord S3 | Philips North America LLC | IYE | Class II | |
| K894051 | Premier-Total Hip | Intermedics Orthopedics | LWJ | Class II | |
| K894041 | Pump-Ject Syringe with Luer-Lock | Ziehm International, Inc. | FRN | Class II | |
| K894037 | Ivac(r) Space.saver(tm) Volumetric Pump Model 599 | Y | FRN | Class II | |
| K894015 | Water Pik(r) | Teledyne Water Pik | EFS | Class I | |
| K894000 | Thera-Mist Humidifier | Pegasus Research Corp. | BTT | Class II | |
| K893942 | Thera-Mist(tm) Nebulizer, Model 30000 | Pegasus Research Corp. | CAF | Class II | |
| K893917 | Emds Triglyceride (Trig), Item Number 65421 | Em Diagnostic Systems, Inc. | CDT | Class I | |
| K893916 | Emds Cholesterol (Cho), Item Number 65410 | Em Diagnostic Systems, Inc. | CHH | Class I | |
| K893809 | Cough Pillow | Custom Hospitals Products | KMO | Class I | |
| K893729 | Hobbs Medical Microbiology Brush | Hobbs Medical, Inc. | FDX | Class II | |
| K893613 | Statspin Mini-Plasma | Statspin Technologies | JKA | Class II | |
| K892653 | Tomax Ultrascan | Incubation Industries, Inc. | IZF | Class II | |
| K892370 | Digital Transtelephonic ECG Monitoring System | Bio-Focus, Inc. | DXH | Class II | |
| K892230 | Rci Viral/bacterial Filter | Respiratory Care, Inc. | CAH | Class II | |
| K892210 | Multi-Drug(tm) Infusion System | Halyard Health | FRN | Class II | |
| K892047 | Patient Examination Gloves (Latex) | Gainlite Co., Ltd. | LYY | Class I | |
| K891066 | Danek Wrist Fixator | Danek Medical, Inc. | KTT | Class II | |
| K894055 | Minix 8341M and Minix St 8331M Pulse Generators | Medtronic, Inc. | DXY | Class III | |
| K893909 | Modified Material Used in Infusion T | Quinton, Inc. | FPA | Class II | |
| K893561 | Edentrace 670 System Multichannel Recorder W/oxim. | Edentec Corp. | DSF | Class I | |
| K892795 | Pulse Time Products Limited, Pm-3 | Pulse Time Products, Ltd. | DRT | Class II | |
| K892794 | Pulse Time Products Limited, Pm-2 | Pulse Time Products, Ltd. | DRT | Class II | |
| K892413 | Patient Examination Gloves (Latex) | Beijing Jian Xing Latex Products Co., Ltd. | LYY | Class I | |
| K892179 | Disposable Latex Examination Gloves | Rex Latex Products Co., Ltd. | LYY | Class I | |
| K892175 | Correct Touch Examination Gloves (Latex) | Ampri Rubberware Industries Sdn Bhd | LYY | Class I | |
| K892045 | Latex Examination Gloves, Non-Sterile | C.N. Technocrats | LYY | Class I | |
| K892034 | Patient Examination Gloves (Latex) | Sistem Med-Pro (M) Sdn Bhd | LYY | Class I | |
| K891667 | Evergood Brand (Patient Exam Gloves-Latex) | San HU Chemical Industry Co., Ltd. | LYY | Class I | |
| K891097 | Damor Cream Saturated Dressing | Damor America, Inc. | FRO | Unclassified | |
| K890988 | Model 3110 Heart Wire & 3110P Pediatric Heart Wire | Pace Medical | LDF | Class II | |
| K890788 | Adx Cocaine Metabolite | Abbott Medical | DIO | Class II | |
| K890743 | Ad X(tm) Ethanol | Abbott Medical | DIC | Class II | |
| K890693 | Adx Cannabinoids | Abbott Medical | LDJ | Class II | |
| K890692 | Adx Amphetamine/methampheamine | Abbott Medical | DKZ | Class II | |
| K890691 | Adx Tm Benzodiazepines | Abbott Medical | JXM | Class II | |
| K890690 | Adx Tm Barbiturates | Abbott Medical | DIS | Class II |