Atlas FDA

MERIT ADMINISTRATION SET

FDA 510(k) clearance K915678 · decided 1992-07-30

Clearance details

K-number
K915678
Device name
MERIT ADMINISTRATION SET
Applicant
Merit Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
1991-12-19
Decision date
1992-07-30
Days to decision
224 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Salt Lake City, UT, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Merit Medical Systems

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
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and sali recall (Z-0649-2017)Merit Medical Systems, Inc.2016-11-21
Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For manufacturing, proces recall (Z-1800-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K09-05785FP, Caution: For manufacturing, proces recall (Z-1801-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K09-05971AP, Caution: For manufacturing, proces recall (Z-1802-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K09-02842CP, Caution: For manufacturing, proces recall (Z-1803-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For manufacturing, process recall (Z-1804-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K09-09051P, Caution: For manufacturing, process recall (Z-1805-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K09-01280JP, Caution: For manufacturing, proces recall (Z-1806-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K10-01795DP, Caution: For manufacturing, proces recall (Z-1807-2008)Merit Medical Systems, Inc.2008-09-11
Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Merit Medical Systems, recall (Z-0843-2007)Merit Medical Systems, Inc.2007-05-31
Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid administration sets, 40000. recall (Z-0844-2007)Merit Medical Systems, Inc.2007-05-31
Custom 72inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid administration sets, M recall (Z-0845-2007)Merit Medical Systems, Inc.2007-05-31
Custom Kit, Cardiac Cath Kit, Rx only, REF/CAT No.: K09-90240HP, Merit Medical Systems, So recall (Z-0846-2007)Merit Medical Systems, Inc.2007-05-31
Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., recall (Z-0847-2007)Merit Medical Systems, Inc.2007-05-31

PMA approvals by this applicant

RecordFirmDate
WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004)Merit Medical Systems, Inc.2025-12-11
WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001)Merit Medical Systems, Inc.2025-02-12
WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002)Merit Medical Systems, Inc.2025-02-12
WRAPSODY® Cell-Impermeable Endoprosthesis (P240023)Merit Medical Systems, Inc.2024-12-19