Atlas FDA

LHI

206 FDA 510(k) clearances · Product code

89 daysmedian time to decision
282 days90th percentile
206clearances measured

FDA profile

Official device name
Set, I.V. Fluid Transfer
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 933 · 2022: 1,834 · 2023: 1,047 · 2024: 1,270 · 2025: 1,356 · 2026: 935
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ADRx™ Admixture Device (K252987)Epic Medical Pte. , Ltd.2026-06-12
Vial Adapter (K260301)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.2026-06-05
Medline Bag Decanter (K250345)Medline Industries, LP2025-10-24
FlowArt® Vial Access Device Vented (K251715)Asset Medikal2025-10-14
Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) (K251676)Microtek Medical, LLC2025-09-16
HyHub™ and HyHub™ Duo Vial Access Devices (K243404)Takeda Pharmaceuticals2025-07-18
Arisure® Closed Male Luer with Spike Adapter (YM060) (K240761)Yukon Medical, LLC2025-03-21
Rio™ Drug Reconstitution Transfer Device (K243985)Icu Medical, Inc.2025-01-22
SmartSiteTM Vented Vial Access Device (K243486)Yukon Medical, LLC2024-12-06
nextaro® va, 15mm, 5µm (K241976)Sfm Medical Devices GmbH2024-09-06
Vent Vial Adapter (K233287)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.2024-07-26
FlowArt Valve for Vial Access (K232987)Asset Medikal Tasarim Sanayi VE Ticaret A.S.2024-06-26
Vial2Bag Advanced® 20mm Admixture Device (K240940)West Pharmaceutical Services, Inc.2024-05-03
Vial Adapter with Filter (K233284)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.2024-05-01
nextaro® v, 20/20 (K240748)Sfm Medical Devices GmbH2024-04-16
BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device (K233021)Care Fusion2024-03-06
Mix2Vial® Transfer Device (K231071)West Pharma. Services IL, Ltd.2024-01-19
Vial Adapter 20mm (K232875)West Pharma. Services IL, Ltd.2023-12-14
Vial2Bag Advanced® 13mm Admixture Device (K230988)West Pharma. Services IL, Ltd.2023-12-01
Vial Adapter (K232055)Shanghai Lingfu Technology Co., Ltd.2023-10-06
MixJect® Transfer Device (K230464)West Pharma. Services IL, Ltd.2023-05-22
Vial Adapter (K222718)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.2023-03-10
Vented Vial Adapter 20mm (K213513)West Pharma. Services IL, Ltd.2022-08-31
Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices (K212525)Advcare Medical2022-08-19
Vial Adapter Ø13mm (K220856)Avenir Performance Européenne Medical (Apem)2022-06-21
freeflex+ Transfer Adapter (K212445)Fresenius Kabi AG2022-06-01
IVX Fluid Transfer Set (K212530)Omnicell, Inc.2022-04-24
SOL-CARE IV Bag Safety Connector (K202732)Sol-Millennium Medical Group2021-11-03
B Dispensing Line (K203674)Aea Srl2021-09-27
ProntoPump Sterile Tube Set (K200893)Ipax, Inc.2021-05-04
Mini Spike Plus 6/8R (K201469)B.Braun Medical, Inc.2020-12-09
Vial2Bag Advanced 20mm Admixture Device (K201415)West Pharmaceutical Services Az, Inc.2020-10-21
Rio Vial-to-Bag Drug Reconstitution Device (K192154)Icu Medical2020-04-20
Decanting Device (K182819)Gcmedica Enterprise Ltd.(Wuxi)2019-12-02
Vial Adapter Ø20 mm , Vial Adapter Ø13 mm (K190816)Avenir Performance Europeenne Medical (Apem)2019-11-19
Vial Adapter Ø20 mm (K190149)Avenir Performance Europeenne Medical (Apem)2019-10-15
nextaro Transfer System, nextaro va (K183187)Sfm Medical Devices GmbH2019-03-15
Guarded Luer Connector (K173577)International Medical Industries, Inc.2018-06-07
GRI-FILL PERISTALTIC SET (K162216)Laboratorios Grifols, S.A.2017-10-19
Vial Adapter 15mm (K171796)Medimop Medical Project , Ltd.2017-10-12
Arisure Closed Vial Adapter (K172884)Yukon Medical2017-10-03
Arisure Dry Spike (K172631)Yukon Medical2017-09-29
Vial2Bag Direct Connect (K170095)Medimop Medical Project , Ltd.2017-03-08
OnSite-IV (K161800)Pharmc, LLC2016-12-06
Vented Vial Adapter Transfer Device - 13mm (K160503)Medimop Medical Projects, Ltd.2016-05-04
APEX Compounding System Transfer Set (K151423)B.Braun Medical, Inc.2016-02-19
KIRO Set (K152441)Kiro Robotics S.L.2015-12-04
Universal Spike (K150787)B.Braun Medical, Inc.2015-12-02
SmartSite Vented Vial Access Device (K151963)Yukon Medical, LLC2015-07-31
VIAL-MATE Adaptor (K142600)Baxter Healthcare Corporation2014-11-19
VIAL2BAG DIRECT CONNECT (K140730)Medimop Medical Projects, Ltd.2014-06-12
MEDSOURCE SELECTABLE IV SET (K140442)Medsource International, LLC2014-04-22
MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET (K140402)Medsource International, LLC2014-04-03
E-Z LINK (K133097)Duoject Medical Systems, Inc.2014-03-13
ADD-VANTAGE ADDAPTOR (K133602)Hospira, Inc.2014-01-24
DISPOSABLE INFUSION SET (K131646)Shanghai Jinta Medical Co., Ltd.2013-11-26
SMARTSITE VIALSHIELD (K132863)Yukon Medical, LLC2013-10-04
MP VIAL ADAPTER 13MM (K130179)Medimop Medical Projects, Ltd.2013-08-08
VIAL CONNECTOR 13MM CLOSED COLLAR (K132040)Medimop Medical Projects, Ltd.2013-07-31
PROTECTOR, INJECTOR, CONNECTOR (K120384)Bd Medical-Medical Surgical Systems2012-09-12
VIALOK SINGLE VIAL ACCESS DEVICE VENTED (K122265)Yukon Medical, LLC2012-08-14
MEDSOURCE IV ADMINSTRATION SET (K120424)Medsource International, LLC2012-07-11
DUAL SPIKE TRANSFER DEVICE (K120150)B.Braun Medical, Inc.2012-05-24
VIALOK NON-VENTED (K121182)Yukon Medical, LLC2012-05-03
MEDLINE VIAL DECANTER (K111577)Medline Industries, Inc.2011-09-08
INFUSION ADAPTER C100 (K110023)Carmel Pharma Ab.2011-04-12
FLEBOSET DOUBLE (K102590)Laboratorios Grifols, S.A.2011-01-13
EQUASHIELD SYSTEM PROTECTIVE PLUS (K101940)Equashield Medical , Ltd.2010-11-19
EXELINT ALUMINUM HUB BLUNT NEEDLES (K101309)Exelint International, Co.2010-10-20
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 (K100640)B.Braun Medical, Inc.2010-07-22
SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K090917)Baxa Corp.2010-02-19
SET GRI-FILL 3.0 (K093182)Laboratorios Grifols, S.A.2010-01-27
INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, (K092782)Carmel Pharma Ab.2009-12-07
NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 (K092246)Nipro Medical Corporation2009-11-12
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE (K092318)Baxter Healthcare Corporation2009-10-30
EQUALSHIELD LUER LOCK CONNECTOR PAIR (K091389)Plastmed, Ltd.2009-10-22
INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 (K083851)Inviro Medical Devices, Inc.2009-05-15
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE (K090905)B.Braun Medical, Inc.2009-04-27
PHASEAL PROTECTOR P14, P21, P28 AND P50 (K090634)Carmel Pharma Ab.2009-03-23
EQUASHIELD SYSTEM (K083152)Plastmed, Ltd.2009-02-02
NEXUS I.V. FLUID TRANSFER DEVICE (K080976)Nexus Medical, LLC2008-11-10
QUICKPIN (K082752)Laboratorios Grifols, S.A.2008-09-29
PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C (K080174)Cardio Med Supplies, Inc.2008-04-23
SMART-ROD (K070584)Duoject Medical Systems, Inc.2008-04-02
SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM (K072511)Medimop Medical Projects, Ltd.2007-12-13
VIAL2BAG (K072759)Medimop Medical Projects, Ltd.2007-12-13
TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K071741)Migada Plant2007-09-24
VENTED VIAL ADAPTER TRANSFER DEVICE (K062482)Medimop Medical Projects, Ltd.2006-11-03
PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS (K060866)Carmel Pharma Ab.2006-04-28
SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD (K052790)Cardinal Health, Alaris Products2005-12-23
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM (K051669)Migada Plant2005-09-01
SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE (K050339)Laboratorios Grifols, S.A.2005-02-25
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 (K043304)Bioject Medical Technologies, Inc.2005-01-14
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET (K041222)B.Braun Medical, Inc.2004-10-14
BAXJECT II (K042410)Baxter Healthcare Corp2004-10-08
CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT (K041691)West Pharmaceutical Services, Inc.2004-08-05
GETTIG UNIVERSAL VIAL ACCESS PIN (K041232)Gettig Pharmaceutical Instrument Co.2004-07-22
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 (K041564)Bioject Medical Technologies, Inc.2004-07-16
ROBERTSITE VIAL ADAPTER, MODEL 245700021 (K040634)Halkey-Roberts Corp.2004-03-23
FLEBOSET MULTIPLE (K040456)Laboratorios Grifols, S.A.2004-03-09
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Every clearance here is in the API, with alerts when new ones post.