Atlas FDA

INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS

FDA 510(k) clearance K142036 · decided 2014-08-25

Clearance details

K-number
K142036
Device name
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
Applicant
B.Braun Medical, Inc.
Decision
Substantially Equivalent
Date received
2014-07-28
Decision date
2014-08-25
Days to decision
28 days
Clearance type
Special
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Allentown, PA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch B.Braun Medical

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
iiSure Infusion Set (K261530)Deka Research and Development2026-06-03
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) (K252543)Amsino International, Inc.2026-05-04
PuraCath Firefly Needleless Connector IT (9005) (K251375)Puracath Medical, Inc.2026-02-12
nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] (K251257)Np Medical2025-12-04
BD Alaris Pump Infusion Set (K250325)Carefusion (Bd)2025-10-30
EZ™ IV Administration Set (K251814)Epic Medical Pte. , Ltd.2025-08-29
SteadiSet infusion set (K251854)Tandem Diabetes Care2025-08-06
Sparta Infusion Set for Insulin (K243841)Deka Research and Development2025-08-01
Infusomat® Space Volumetric Infusion Pump Administration Sets (K243392)B.Braun Medical, Inc.2025-07-24
Clave™ Neutral-Displacement Needlefree Connectors (K250616)Icu Medical, Inc.2025-06-05
SteadiSet Infusion Set (K242692)Capillary Biomedical, LLC2025-05-09
JetCan® Pro Safety Huber Needle (K242763)Pfm Medical, Inc.2025-05-02

Recalls involving this device

RecordFirmDate
Infusomat utilized in gravity IV administration sets and pump administration sets utilized recall (Z-0640-2026)B Braun Medical Inc2025-11-26
Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion recall (Z-2378-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusi recall (Z-2379-2024)B. Braun Medical, Inc.2024-07-17
Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion recall (Z-2380-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion recall (Z-2381-2024)B. Braun Medical, Inc.2024-07-17
Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pu recall (Z-2382-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infus recall (Z-2383-2024)B. Braun Medical, Inc.2024-07-17
Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for recall (Z-2384-2024)B. Braun Medical, Inc.2024-07-17
Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusio recall (Z-2385-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infus recall (Z-2386-2024)B. Braun Medical, Inc.2024-07-17
Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion p recall (Z-2387-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusi recall (Z-2388-2024)B. Braun Medical, Inc.2024-07-17
Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusio recall (Z-2389-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infus recall (Z-2390-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infus recall (Z-2391-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusi recall (Z-2392-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusi recall (Z-2393-2024)B. Braun Medical, Inc.2024-07-17
Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump recall (Z-2394-2024)B. Braun Medical, Inc.2024-07-17
Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for i recall (Z-2395-2024)B. Braun Medical, Inc.2024-07-17
Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump fo recall (Z-2396-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infus recall (Z-2397-2024)B. Braun Medical, Inc.2024-07-17
Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusio recall (Z-2398-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusi recall (Z-2399-2024)B. Braun Medical, Inc.2024-07-17
Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusio recall (Z-2400-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infu recall (Z-2401-2024)B. Braun Medical, Inc.2024-07-17
Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusio recall (Z-2402-2024)B. Braun Medical, Inc.2024-07-17
Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infus recall (Z-2403-2024)B. Braun Medical, Inc.2024-07-17
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresi recall (Z-0355-2024)B. Braun Medical, Inc.2023-12-01
B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032 recall (Z-2489-2019)B. Braun Medical, Inc.2019-09-23