510(k) clearances

Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set

Sol-Millennium Medical, Inc. · Clinical Chemistry

K260857Substantially EquivalentSpecialJKA
Open FDA's page for this record
Third party flag
N
City
Chicago
Advisory committee description
Clinical Chemistry
Address 1
311 S. Wacker Dr., Suite 4100
Statement or summary
Summary
Product code
JKA
Zip code
60606
Applicant
Sol-Millennium Medical, Inc.
Decision date
2026-10-21
Decision code
SESE
Country code
US
Device name
Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set
Advisory committee
CH
Contact
Mike Xie
K number
K260857
State
IL
Date received
2026-03-16
Review advisory committee
HO
Postal code
60606
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Medical specialty description
Clinical Chemistry
Regulation number
862.1675
Device class
2
Registration number
3008496607, 3030243919, 1055927, 2648045, 3017509841, 3030446844, 3000268902, 3020294761, 3013298431, 3015058854, 3019807891, 1058602, 3026940910, 3030626857, 3037918935, 1917413, 3008337059, 1055236, 3024537844, 3009518015, 3006425876, 9616567, 3005674478, 3013696225, 3009742443, 3016661372, 3042871620, 3043226252, 3003974574, 3033589330, 3005910889, 9681835, 3013652330, 3044026004, 3001124136, 3019004087, 9680794, 8010026, 3014662855, 3035708936 +180 more
FEI number
3008496607, 3030243919, 2648045, 3017509841, 3030446844, 3000268902, 3020294761, 3013298431, 2828, 1000113359, 3003282181, 3015058854, 3019807891, 3000974732, 3026940910, 3030626857, 3037918935, 1000208624, 1917413, 3008337059, 3024537844, 3009518015, 3006425876, 3005674478, 3013696225, 3009742443, 3016661372, 3042871620, 3043226252, 3003974574, 3033589330, 3005910889, 3000206435, 3013652330, 3044026004, 3002808075, 3001236905, 2649711, 3001124136, 3019004087 +180 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.