Cleared Traditional

K990380 - (1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250

Also marketed or referenced as:
(2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700

K990380 is an FDA 510(k) clearance for (1) DIGITAL BLOOD PRESSURE MONITOR, manufactured by Meditec Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K990380 · Meditec Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
14d
Days
Class 2
Risk

K990380 is an FDA 510(k) clearance for the (1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Meditec Co., Ltd. (Sunnamcity, Kyunggido, KR). The FDA issued a Cleared decision on February 22, 1999 after a review of 14 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.

View all Meditec Co., Ltd. devices

FDA 510(k) Submission Details - K990380

510(k) Number K990380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1999
Decision Date February 22, 1999
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
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

Tuv Product Service, Inc.
CAROLE STAMP

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 844
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K990380.
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280
K981431 · Panasonic Corporation (Panasonic) · Mar 1999
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284
K981542 · Panasonic Corporation (Panasonic) · Mar 1999
ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL
K964235 · Industrielle Entwicklung Medizintechnik Und Vertri · Mar 1999
6004 NIBP MONITOR WITH TEMPERATURE
K983796 · Bci Intl., Inc. · Jan 1999
MS-900S, MS-900SPM & MS-900SFM
K980845 · Mars Medical Products · Dec 1998
FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F
K983855 · Jawon Medical Co., Ltd. · Nov 1998