Cleared Traditional

K884111 - PUMPETTE(TM)

K884111 is an FDA 510(k) clearance for PUMPETTE(TM), manufactured by Helena Laboratories. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K884111 · Helena Laboratories · Chemistry device
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Dec 1988
Decision
76d
Days
Class 2
Risk

K884111 is an FDA 510(k) clearance for the PUMPETTE(TM). Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 14, 1988 after a review of 76 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.

FDA 510(k) Submission Details - K884111

510(k) Number K884111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1988
Decision Date December 14, 1988
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 89d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

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 239
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K884111.
STATSPIN MINI-PLASMA
K893613 · Statspin Technologies · Aug 1989
SAFEPETTE DISPENSER
K890109 · Safe-Tec Clinical Products, Inc. · Feb 1989
LIPOCLEAR LIPEMIA CLEARING REAGENT
K884807 · Statspin Technologies · Jan 1989
CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE
K883813 · Ciba Corning Diagnostics Corp. · Nov 1988
MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE
K883320 · Sherwood Medical Co. · Sep 1988
MONOJECT(R) SNAP-OVER SAFETY CAP
K882614 · Sherwood Medical Co. · Aug 1988
K884111 · PUMPETTE(TM)
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