Cleared Traditional

IMPRA PERITONEAL CATHETER (K823857) - FDA 510(k) Clearance

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

K823857 · Impra, Inc. · Gastroenterology & Urology device

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Jan 1983

Decision

35d

Days

Class 2

Risk

K823857 is an FDA 510(k) clearance for the IMPRA PERITONEAL CATHETER. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Impra, Inc. (Walker, US). The FDA issued a Cleared decision on January 26, 1983 after a review of 35 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 Impra, Inc. devices

Submission Details

510(k) Number	K823857 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 22, 1982
Decision Date	January 26, 1983
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

95d faster than avg

Panel avg: 130d · This submission: 35d

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 37

Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K823857.

AUTOMATIC PERITONEAL DIALYSIS CYCLER

K833065 · Travenol Laboratories, S.A. · Nov 1983

ABBOTT PATIENT ASSIST DEVICE

K830766 · Abbott Laboratories · Mar 1983

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

EXTENSION SET TYPE DP

K822658 · Abbott Laboratories · Oct 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K823857

Impra, Inc.

Walker, MI · US

Regulatory profile

29 submissions 24 cleared

83% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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