Cleared Traditional

K933996 - PROFIBLOT

K933996 is an FDA 510(k) clearance for PROFIBLOT, manufactured by Tecan U.S., Ltd.. The device is a Class 1 Pathology device with product code KPA cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K933996 · Tecan U.S., Ltd. · Pathology device
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Optimized for regulatory review, auditing and printing
Jan 1994
Decision
164d
Days
Class 1
Risk

K933996 is an FDA 510(k) clearance for the PROFIBLOT. Classified as Slide Stainer, Automated (product code KPA), Class I - General Controls.

Submitted by Tecan U.S., Ltd. (Hillsborough, US). The FDA issued a Cleared decision on January 28, 1994 after a review of 164 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3800 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tecan U.S., Ltd. devices

FDA 510(k) Submission Details - K933996

510(k) Number K933996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1993
Decision Date January 28, 1994
Days to Decision 164 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 77d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

KPA Device Classification - Class 1, General Controls

Product Code KPA Slide Stainer, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KPA Slide Stainer, Automated

All 10
Devices cleared under the same product code (KPA) and FDA review panel - the closest regulatory comparables to K933996.
LX-100 SLIDE STAINER
K880745 · Innovative Medical Systems, Inc. · Apr 1988
HISTOMATIC SLIDE STAINER, CODE-ON VERSION
K872916 · Fisher Scientific Co., LLC · Sep 1987
CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS
K850157 · Shaban Mfg. Co. · Feb 1985
PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS
K850333 · Shaban Mfg. Co. · Feb 1985
MIDAS II AUTOMATIC STAINER
K842077 · Innovative Medical Systems, Inc. · Jul 1984
MIDAS 6000 AUTOMATIC STAINER
K832994 · Innovative Medical Systems, Inc. · Sep 1983