Cleared Traditional

K895868 - HEYER-SCHULTE DISPOSABLE PERITONEAL CAT...

K895868 is the FDA 510(k) clearance for HEYER-SCHULTE DISPOSABLE PERITONEAL CAT... by Baxter Healthcare Corp. It is a Class 1 Neurology device (product code GYK) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K895868 · Baxter Healthcare Corp · Neurology device
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Oct 1989
Decision
27d
Days
Class 1
Risk

K895868 is an FDA 510(k) clearance for the HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE. Classified as Instrument, Shunt System Implantation (product code GYK), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4545 - the FDA neurology 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K895868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1989
Decision Date October 31, 1989
Days to Decision 27 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 148d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GYK Instrument, Shunt System Implantation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4545
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GYK Instrument, Shunt System Implantation

All 12
Devices cleared under the same product code (GYK) and FDA review panel - the closest regulatory comparables to K895868.
V/P AND L/P CATHETER PASSERS
K934391 · Radionics, Inc. · Nov 1993
PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
K930606 · Pudenz-Schulte Medical Research Corp. · Sep 1993
CORDIS TUNNELER
K932273 · Cordis Corp. · Aug 1993
PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
K883607 · Codman & Shurtleff, Inc. · Sep 1988
HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
K873771 · American V. Mueller · Dec 1987
H-H SUBGALEAL TROCAR
K865075 · Holter-Hausner Intl. · Jan 1987