Cleared Traditional

K911638 - SYRINGE TIP CAP

K911638 is the FDA 510(k) clearance for SYRINGE TIP CAP by Concord/Portex. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K911638 · Concord/Portex · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
71d
Days
Class 2
Risk

K911638 is an FDA 510(k) clearance for the SYRINGE TIP CAP. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Concord/Portex (Keene, US). The FDA issued a Cleared decision on June 21, 1991 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Concord/Portex devices

Submission Details

510(k) Number K911638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1991
Decision Date June 21, 1991
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 103
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K911638.
VACUTAINER BRAND LUER ADAPTER
K921520 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1992
VACUTAINER(R) BRAND SST(R) AND CAT TUBES
K921806 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
QBC E-Z PREP
K913399 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
VACUTAINER PLUS WITH HEMOGARD CLOSURE
K901449 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
VENOJECT II BLOOD COLLECTION TUBES
K900309 · Terumo Medical Corp. · Mar 1990
PUMPETTE(TM)
K884111 · Helena Laboratories · Dec 1988