Cleared Traditional

K200321 - Novaerus NV1050

K200321 is an FDA 510(k) clearance for Novaerus NV1050, manufactured by Novaerus Us, Inc.. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K200321 · Novaerus Us, Inc. · General Hospital
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Dec 2020
Decision
322d
Days
Class 2
Risk

K200321 is an FDA 510(k) clearance for the Novaerus NV1050. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Novaerus Us, Inc. (Stamford, US). The FDA issued a Cleared decision on December 28, 2020 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5045 - 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 Novaerus Us, Inc. devices

FDA 510(k) Submission Details - K200321

510(k) Number K200321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2020
Decision Date December 28, 2020
Days to Decision 322 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 129d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRF Device Classification - Class 2, Special Controls

Product Code FRF Cleaner, Air, Medical Recirculating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5045
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 - FRF Cleaner, Air, Medical Recirculating

All 23
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