Cleared Traditional

K002839 - END EXPIRATORY FILTER, MODEL RT020 (FDA 510(k) Clearance)

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

K002839 · Fisher &Paykel Healthcare , Ltd. · General Hospital
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Oct 2001
Decision
387d
Days
Class 2
Risk

K002839 is an FDA 510(k) clearance for the END EXPIRATORY FILTER, MODEL RT020. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (East Tamaki, Auckland, NZ). The FDA issued a Cleared decision on October 4, 2001 after a review of 387 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Fisher &Paykel Healthcare , Ltd. devices

Submission Details

510(k) Number K002839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2000
Decision Date October 04, 2001
Days to Decision 387 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
259d slower than avg
Panel avg: 128d · This submission: 387d
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 200
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K002839.
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K221472 · Ningbo Huakun Medical Equipment Co., Ltd. · Feb 2023