Cleared Traditional

K212268 - FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT

K212268 is an FDA 510(k) clearance for FMD Peripheral Guide Wires F-14 and F-18, manufactured by FMD Co., Ltd.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K212268

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.

DQX Device Classification - Class 2, Special Controls

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 681
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