SWABCAP AND SWABFLUSH— 510(k) K130975

Substantially Equivalent

Excelsior Medical Corp.

FDA 510(k) clearance K130975 for SWABCAP AND SWABFLUSH, Substantially Equivalent on 2013-12-24. Applicant: Excelsior Medical Corp.. Device class: 2.

Clearance details

Applicant: Excelsior Medical Corp.
Product code: Code QBP
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2013-04-08
Decision date: 2013-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QBP

K252006 — OTTO Disinfecting Cap2026-03-27
K251592 — SteriHub Disinfecting Device and Protective Cover2026-02-11
K223914 — ACTIV Cap2024-04-05
K193190 — BD PureHub Disinfecting Cap2020-11-09
K200299 — Curos Jet Disinfecting Cap2020-10-29

More clearances from Excelsior Medical Corp.

K101270 — SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 103112011-02-10
K083508 — SWABCAP2009-04-28
K082837 — STERILE FIELD SALINE PRE-FILLED SYRINGE(S)2008-12-18
K061497 — SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML2007-02-23
K053120 — STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES2005-12-09

Recalls naming K130975

K-number listed on FDA's recall record

Z-2199-2025 — SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301Class II·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·20250616
Z-2116-2025 — SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000Class II·Ongoing·ICU Medical, Inc.·20250603

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130975.

Data sourced from openFDA. This site is unofficial and independent of the FDA.