Cleared Traditional

SERVO GUARD, MODEL 64 81 290 EH88E (K030071) - FDA 510(k) Clearance

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

K030071 · Maquet, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
474d
Days
Class 2
Risk

K030071 is an FDA 510(k) clearance for the SERVO GUARD, MODEL 64 81 290 EH88E. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Maquet, Inc. (Bridgewater, US). The FDA issued a Cleared decision on April 26, 2004 after a review of 474 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Maquet, Inc. devices

Submission Details

510(k) Number K030071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2003
Decision Date April 26, 2004
Days to Decision 474 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
345d slower than avg
Panel avg: 129d · This submission: 474d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 19
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K030071.
Altera Filter and HME/Filter
K192713 · Meditera Tibbi Malzeme San VE Tic AS · Mar 2020
Servo Guard
K182862 · Maquet Critical Care AB · Oct 2019
SafeBreath Filter Mouthpiece
K190022 · MD Diagnostics Limited · Sep 2019
MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
K925217 · Merit Medical Systems, Inc. · Jan 1993
3M BRAND ANESTHESIA FILTER,#3110
K760611 · 3M Company · Sep 1976
FILTER, RESPIRATORY (U-MID)
K760041 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1976