Cleared Traditional

CATHETER BUBBLE STAND (K813487) - FDA 510(k) Clearance

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

K813487 · Accurate Surgical Instruments Co. · Gastroenterology & Urology device
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Dec 1981
Decision
30d
Days
Class 2
Risk

K813487 is an FDA 510(k) clearance for the CATHETER BUBBLE STAND. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Accurate Surgical Instruments Co. (Walker, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 30 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 Accurate Surgical Instruments Co. devices

Submission Details

510(k) Number K813487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1981
Decision Date December 31, 1981
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
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 32
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K813487.
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
DIALYSIS DRAINAGE UNIT, PERITONEAL
K772150 · C.R. Bard, Inc. · Nov 1977