Cleared Traditional

K012054 - FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312

K012054 is an FDA 510(k) clearance for FULL AUTO WRIST DIGITAL BLOOD PRESSURE ..., manufactured by Sein Electronics Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K012054 · Sein Electronics Co., Ltd. · Cardiovascular device
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Aug 2001
Decision
37d
Days
Class 2
Risk

K012054 is an FDA 510(k) clearance for the FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Sein Electronics Co., Ltd. (Anyang-City, Kyunggi-Do, KR). The FDA issued a Cleared decision on August 8, 2001 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K012054

510(k) Number K012054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2001
Decision Date August 08, 2001
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 Consultant

Underwriters Laboratories, Inc.
MOLLY BETTGER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 1213
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K012054.
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K012054 · FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
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