Cleared Traditional

K810795 - INSTAFIL

K810795 is an FDA 510(k) clearance for INSTAFIL, manufactured by Instafil, Inc.. The device is a Class 2 Chemistry device with product code KPE cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K810795 · Instafil, Inc. · Chemistry device
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Jun 1981
Decision
81d
Days
Class 2
Risk

K810795 is an FDA 510(k) clearance for the INSTAFIL. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Instafil, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5025 - 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 Instafil, Inc. devices

FDA 510(k) Submission Details - K810795

510(k) Number K810795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1981
Decision Date June 12, 1981
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 88d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPE Device Classification - Class 2, Special Controls

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
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 - KPE Container, I.v.

All 60
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K810795.
CAT 3040
K830193 · Burron Medical Products, Inc. · Mar 1983
DELMED IV CONTAINER
K830450 · Delmed, Inc. · Mar 1983
SOLUTION TRANSFER CONTAINER
K830299 · The Healthcare Group Laboratories, Inc. · Feb 1983
TOTAL PARENTERAL NUTRITION SET BAG
K801652 · Cutter Laboratories, Inc. · Aug 1980
LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN
K791774 · Abbott Laboratories · Oct 1979
ADDITIVE HINGE CAP
K791796 · Abbott Laboratories · Oct 1979