Panels › General Hospital › Product code FPA · Class 2
Set, Administration, Intravascular
Regulation 880.5440
6510(k)s in 12 months (1,176 all time)
110recalls in 12 months (1,090 all time)
1,030recalls that name a 510(k)
Top companies in FPA
| Company | 510(k)s | Recalls |
|---|---|---|
| B.Braun Medical, Inc. | 23 | 234 |
| Baxter Healthcare Corp | 67 | 151 |
| Icu Medical, Inc. | 27 | 187 |
| Hospira, Inc. | 14 | 109 |
| Smiths Medical MD, Inc. | 4 | 37 |
| Churchill Medical Systems, Inc. | 7 | 32 |
| CME America, LLC | 0 | 38 |
| Abbott Laboratories | 30 | 0 |
| Y | 28 | 0 |
| Carefusion, Inc. | 1 | 25 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 18, 2022 | K212842 | Microvolume Luer Access Device B.Braun Medical, Inc. | FPA |
| Nov 10, 2021 | K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector Ivenix, Inc. | FPA |
| Sep 30, 2021 | K203609 | Intravascular Administration Sets Baxter Healthcare Corporation | FPA |
| Sep 24, 2021 | K202618 | IV Administration Sets B.Braun Medical, Inc. | FPA |
| Aug 14, 2021 | K210381 | I.V. Administration Set Bq Plus Medical Co., Ltd., CN | FPA |
| Aug 13, 2021 | K202279 | Insignis Subcutaneous Needle Sets Innovative Health Sciences, LLC | FPA |
| Jul 30, 2021 | K203796 | Firefly Needleless Connector Puracath Medical, Inc. | FPA |
| Jul 16, 2021 | K210544 | Medtronic Extended infusion set Unomedical A/S, DK | FPA |
| Jun 18, 2021 | K210430 | Intravascular Extension Set Baxter Healthcare Corporation | FPA |
| May 17, 2021 | K210217 | Needleless Connector Jiangsu Caina Medical Co.,Ltd, CN | FPA |
| Mar 24, 2021 | K201626 | Safety Subcutaneous Infusion Set Epic Medical Pte. , Ltd., SG | FPA |
| Feb 23, 2021 | K200439 | Velano ExT Extension Set Velano Vascular | FPA |
| Jan 21, 2021 | K202672 | Precision Delivery Infusion Set Quest Medical, Inc. | FPA |
| Jan 5, 2021 | K201872 | NeutrArt Asset Medikal Tasarim As., TR | FPA |
| Oct 29, 2020 | K200425 | Female Luer Lock Cap Medsafety Solutions, LLC | FPA |
| Oct 23, 2020 | K193088 | MaxZero Extension Sets with Needle-Free Connector(s) Carefusion, Inc. | FPA |
| Oct 8, 2020 | K200661 | Steripath Micro Blood Collection System Magnolia Medical Technologies, Inc. | FPA |
| Sep 18, 2020 | K192375 | Intellifuse Administration and Intellifuse Blood Administration Sets Smiths Medical Asd, Inc. | FPA |
| Aug 26, 2020 | K191640 | TK Intravascular Administration Set Anhui Tiankang Medical Technology Co., Ltd., CN | FPA |
| Jul 28, 2020 | K192681 | Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle ho Jiangsu Kangbao Medical Equipment Co., Ltd., CN | FPA |
| Jul 20, 2020 | K192366 | Intravascular Extension Sets and Accessories Baxter Healthcare Corporation | FPA |
| May 20, 2020 | K191362 | LifeFlow Blood System 410 Medical, Inc. | FPA |
| Mar 19, 2020 | K191658 | IV Sets not made with PVC B.Braun Medical, Inc. | FPA |
| Feb 20, 2020 | K190806 | Flowart Asset Medikal Tasarim As., TR | FPA |
| Dec 13, 2019 | K192647 | neria guard Infusion Set Unomedical A/S, DK | FPA |
| May 28, 2019 | K180739 | Clearlink System Solution Set Baxter Healthcare Corporation | FPA |
| May 2, 2019 | K190233 | K-Shield Advantage Port Access Infusion Set (PAIS) Kawasumi Laboratories, Inc., JP | FPA |
| Apr 4, 2019 | K180843 | HIgH-Flo Super26 Subcutaneous Needle Sets Repro-Med Systems, Inc. Dba Rms Medical Products | FPA |
| Mar 26, 2019 | K182897 | Velano Vascular Q2 Extension Set Velano Vascular | FPA |
| Feb 26, 2019 | K181870 | Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Wuhan W.E.O Science & Technology Development Co., Ltd., CN | FPA |
| Jan 11, 2019 | K182545 | Tamper Evident Cap with Male Luer Lock International Medical Industries, Inc. | FPA |
| Oct 18, 2018 | K181718 | BD FlowSmart Set/MiniMed Pro-Set Becton, Dickinson and Company | FPA |
| Sep 5, 2018 | K173665 | AMSafe Sure-Lok Needle-Free Connector Amsino International, Inc. | FPA |
| Jun 26, 2018 | K173361 | IV Administration Set B.Braun Medical, Inc. | FPA |
| Mar 5, 2018 | K173879 | MiniMed Mio Advance infusion set Unomedical A/S, DK | FPA |
| Nov 7, 2017 | K170595 | IV Administration Sets B.Braun Medical, Inc. | FPA |
| Nov 1, 2017 | K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Unomedical A/S, DK | FPA |
| Sep 22, 2017 | K172544 | IV Fat Emulsion Administration Sets Baxter Healthcare Corporation | FPA |
| Sep 19, 2017 | K170002 | Medline Blood Collection Set Medline Industries, Inc. | FPA |
| Sep 1, 2017 | K171117 | Carefusion NeutraClear Needle-free connector (EL-NC1000) Cair Lgl, FR | FPA |
| Aug 15, 2017 | K171118 | Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) Cair Lgl, FR | FPA |
| Jul 31, 2017 | K171132 | Carefusion NeutraClear Needle-free connector Cair Lgl, FR | FPA |
| Jul 28, 2017 | K162951 | TUBETECH IV Administration Set Douglas Medical Products, Inc. | FPA |
| Jul 19, 2017 | K171957 | MaxZero Extension Sets with Needless Connector Carefusion 303, Inc. | FPA |
| Jun 21, 2017 | K161808 | Solution Set with 1.2 Micron Air Eliminating Filter Baxter Healthcare Corporation | FPA |
| Jun 15, 2017 | K162826 | Encore Neutral Rymed Technologies, LLC | FPA |
| Jun 2, 2017 | K171101 | Closed Male Luer Yukon Medical | FPA |
| May 31, 2017 | K162601 | Infusion Set for Single Use Shinva Ande Healthcare Apparatus Co., Ltd., CN | FPA |
| Apr 20, 2017 | K163160 | Sterile Single-use Infusion Set Jiangxi Hongda Medical Equipment Group , Ltd., CN | FPA |
| Mar 8, 2017 | K162804 | Q2 Low Pressure Power Injection Extension Set Quest Medical, Inc. | FPA |
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