Atlas FDA

CADD MEDICATION CASSETTE RESERVOIR

FDA 510(k) clearance K081156 · decided 2008-07-18

Clearance details

K-number
K081156
Device name
CADD MEDICATION CASSETTE RESERVOIR
Applicant
Smiths Medical MD, Inc.
Decision
Substantially Equivalent
Date received
2008-04-23
Decision date
2008-07-18
Days to decision
86 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
St. Paul, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 recall (Z-0010-2025)Smiths Medical ASD Inc.2024-10-18
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 recall (Z-0011-2025)Smiths Medical ASD Inc.2024-10-18
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 recall (Z-0012-2025)Smiths Medical ASD Inc.2024-10-18
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 recall (Z-0013-2025)Smiths Medical ASD Inc.2024-10-18
CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24 recall (Z-0014-2025)Smiths Medical ASD Inc.2024-10-18
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP recall (Z-0015-2025)Smiths Medical ASD Inc.2024-10-18
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP recall (Z-0016-2025)Smiths Medical ASD Inc.2024-10-18
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28 recall (Z-0017-2025)Smiths Medical ASD Inc.2024-10-18
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 recall (Z-0018-2025)Smiths Medical ASD Inc.2024-10-18
CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-731 recall (Z-0964-2023)Smiths Medical ASD Inc.2023-01-30