Cleared Traditional

K791796 - ADDITIVE HINGE CAP (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K791796 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1979
Decision
17d
Days
Class 2
Risk

K791796 is an FDA 510(k) clearance for the ADDITIVE HINGE CAP. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 1, 1979 after a review of 17 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 Abbott Laboratories devices

Submission Details

510(k) Number K791796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1979
Decision Date October 01, 1979
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K791796.
Disposable Infusion Bag for Parenteral Nutrition
K252079 · Beijing L&Z Medical Technology Development Co., Ltd. · Apr 2026
ClaveQS™ Bag
K251980 · Icu Medical, Inc. · Mar 2026
KabiHelp® Uno
K251139 · Fresenius Kabi AG · Jan 2026
eZSURE™ Empty Fluid Container
K252094 · Epic Medical Pte. , Ltd. · Aug 2025
DMRX 100ml Empty Container Solution
K250459 · Technoflex Sas. · Apr 2025
eZSURE™ Empty Fluid Container with ProSeal™ Injection Site
K241442 · Epic Medical Pte. , Ltd. · Jun 2024