Cleared Traditional

EXTENSION SET TYPE DP (K822658) - FDA 510(k) Clearance

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

K822658 · Abbott Laboratories · Gastroenterology & Urology device
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Oct 1982
Decision
48d
Days
Class 2
Risk

K822658 is an FDA 510(k) clearance for the EXTENSION SET TYPE DP. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 21, 1982 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology 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: 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 K822658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1982
Decision Date October 21, 1982
Days to Decision 48 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 130d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKX System, Peritoneal, Automatic Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FKX System, Peritoneal, Automatic Delivery

All 36
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K822658.
BETA-CAP D ADAPTER
K830208 · Quinton, Inc. · Mar 1983
STERILE, DISPOS. SPIKE PROTECTOR-5C4138
K823777 · Travenol Laboratories, S.A. · Jan 1983
INPERSOL PERITONEAL DIALSIS CYCLER SET
K823217 · Abbott Laboratories · Nov 1982
INPERSOL-CAPD ADMINIS. SET TYPE DP
K822712 · Abbott Laboratories · Oct 1982
AUTOMATIC SPLICING DEVICE
K822025 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1982
DIANEAL SOLUTION EXCHANGE DEVICE #5C4193
K822361 · Travenol Laboratories, S.A. · Aug 1982