Cleared Traditional

K221209 - PRECISION ECO Compostable / Plant Based...

K221209 is an FDA 510(k) clearance for PRECISION ECO Compostable / Plant Based..., manufactured by Padm Medical, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K221209 · Padm Medical, Inc. · General Hospital
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Mar 2023
Decision
316d
Days
Class 2
Risk

K221209 is an FDA 510(k) clearance for the PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Padm Medical, Inc. (Winnipeg, CA). The FDA issued a Cleared decision on March 8, 2023 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Padm Medical, Inc. devices

FDA 510(k) Submission Details - K221209

510(k) Number K221209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2022
Decision Date March 08, 2023
Days to Decision 316 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
187d slower than avg
Panel avg: 129d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 - FXX Mask, Surgical

All 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K221209.
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