Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MRZ — Predicate Candidate Screening
48 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
288 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230718 | UTC 3mL Medication Cartridge | Gilero, LLC | 2023-06-15 | 92 | 0 |
| K220695 | Elite Biomedical Solutions Dose Request Cord | Elite Biomedical Solutions | 2022-04-29 | 51 | 0 |
| K201634 | RG 3ml Medication Cartridge | Chengdu Shifeng Medical Technology Co., Ltd. | 2021-03-26 | 283 | 0 |
| K193654 | BlueStar Rx | Welldoc, Inc. | 2020-04-07 | 99 | 0 |
| K191910 | SpaceStation MRI | B. Braun Melsugen AG | 2020-03-12 | 239 | 7 |
| K190013 | WellDoc BlueStar | Welldoc, Inc. | 2019-11-04 | 305 | 0 |
| K173531 | Lockbox for Perfusor Space PCA Infusion Pump | B.Braun Medical, Inc. | 2018-08-02 | 260 | 0 |
| K171346 | Sapphire Sets | Icu Medical | 2017-08-25 | 109 | 0 |
| K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. | 2017-01-12 | 125 | 0 |
| K160492 | Hospira Sapphire Sets | Hospira, Inc. | 2016-12-06 | 288 | 0 |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and Diabete | Welldoc, Inc. | 2016-11-22 | 106 | 0 |
| K142374 | ivWatch Model 400 | Ivwatch, LLC | 2015-02-13 | 171 | 0 |
| K142333 | SMART LABEL, PROPOFOL | American I.V. Products, Inc. Dba Aiv, Inc. | 2014-12-18 | 119 | 0 |
| K141273 | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE | Welldoc, Inc. | 2014-07-08 | 53 | 0 |
| K132618 | ONETOUCH REVEAL | Lifescan, Inc. | 2013-12-16 | 117 | 0 |
| K120209 | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE | American I.V. Products, Inc. | 2012-04-12 | 79 | 0 |
| K120314 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYST | Welldoc, Inc. | 2012-02-24 | 23 | 0 |
| K112370 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYST | Welldoc, Inc. | 2011-10-14 | 58 | 0 |
| K101806 | AIDERA DIASEND SYSTEM | Aidera AB | 2010-12-07 | 162 | 0 |
| K100066 | DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERS | Welldoc, Inc. | 2010-07-15 | 185 | 0 |
| K091181 | LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS | Smiths Medical MD, Inc. | 2009-06-12 | 50 | 0 |
| K083221 | AIDERA DIASEND | Aidera AB | 2009-02-03 | 95 | 0 |
| K082783 | CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND PO | Smiths Medical MD, Inc. | 2008-12-17 | 85 | 0 |
| K080227 | ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM | Roche Diagnostics Corp. | 2008-05-15 | 106 | 0 |
| K080587 | EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE | Animas Corp. | 2008-05-15 | 73 | 1 |
| K072955 | CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21 | Smiths Medical MD, Inc. | 2008-02-13 | 117 | 0 |
| K070438 | MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 | Medtronic Minimed, Inc. | 2007-10-17 | 244 | 0 |
| K071418 | DANA 3CC SYRINGE INSULIN RESERVOIR | Sooil Development Co., Ltd. | 2007-09-04 | 105 | 0 |
| K051079 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SP | Hospicare, Inc. | 2005-05-19 | 22 | 1 |
| K030936 | RITA CLIPS FOR INFUSION PUMPS | Rita Medical Systems, Inc. | 2003-04-01 | 7 | 0 |
| K023890 | PREPARE CARTRIDGE | Appro Healthcare, Inc. | 2003-02-07 | 78 | 0 |
| K021974 | MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MO | Minimed, Inc. | 2002-08-06 | 50 | 0 |
| K012266 | SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N72 | National Custom Ent., Inc. | 2001-09-12 | 56 | 0 |
| K012262 | BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC | National Custom Ent., Inc. | 2001-09-12 | 56 | 0 |
| K012259 | MEDFUSION 2001 & 2010, MODEL N7215IWC | National Custom Ent., Inc. | 2001-09-12 | 56 | 0 |
| K990091 | S.P.A.R STERILE AMBULATORY RESERVOIR | Faulding Pharmaceutical Co. | 1999-04-04 | 83 | 0 |
| K980165 | INFUTEST 2000 INFUSION DEVICE ANALYZER | Datrend Systems, Inc. | 1998-04-20 | 94 | 0 |
| K961486 | IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KI | Ivac Medical Systems | 1998-04-17 | 732 | 0 |
| K970678 | THE HARVARD LIBRARY | Harvard Apparatus, Inc. | 1998-01-09 | 319 | 0 |
| K972779 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER | Alexander Mfg. Co. | 1997-10-20 | 87 | 0 |
| K972780 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER | Alexander Mfg. Co. | 1997-10-20 | 87 | 0 |
| K962159 | STERILE AMBULATORY RESERVOIR 60ML/100ML | Faulding Medical Device Co. | 1997-07-18 | 409 | 0 |
| K972089 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER | Alexander Mfg. Co. | 1997-07-03 | 29 | 0 |
| K971213 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P | Alexander Mfg. Co. | 1997-05-27 | 55 | 0 |
| K971237 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER | Alexander Mfg. Co. | 1997-05-27 | 55 | 0 |
| K971212 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER | Alexander Mfg. Co. | 1997-05-27 | 55 | 0 |
| K970786 | ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7) | Alexander Mfg. Co. | 1997-05-27 | 84 | 0 |
| K971234 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER | Alexander Mfg. Co. | 1997-05-27 | 55 | 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