Cleared Traditional

K212268 - FMD Peripheral Guide Wires F-14 and F-18

K212268 is the FDA 510(k) clearance for FMD Peripheral Guide Wires F-14 and F-18 by FMD Co., Ltd.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K212268 · FMD Co., Ltd. · Cardiovascular device
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May 2022
Decision
311d
Days
Class 2
Risk

K212268 is an FDA 510(k) clearance for the FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by FMD Co., Ltd. (Shibuya-Ku, JP). The FDA issued a Cleared decision on May 27, 2022 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all FMD Co., Ltd. devices

Submission Details

510(k) Number K212268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2021
Decision Date May 27, 2022
Days to Decision 311 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 125d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 498
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