Cleared Traditional

K942777 - MINIMUS II

Also marketed or referenced as:
MINIMUS II COLOR BABYPHON

K942777 is an FDA 510(k) clearance for MINIMUS II, manufactured by Rudolf Riester GmbH & Co. KG. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K942777 · Rudolf Riester GmbH & Co. KG · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1994
Decision
57d
Days
Class 2
Risk

K942777 is an FDA 510(k) clearance for the MINIMUS II. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on July 27, 1994 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - 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 Rudolf Riester GmbH & Co. KG devices

FDA 510(k) Submission Details - K942777

510(k) Number K942777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1994
Decision Date July 27, 1994
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXQ Device Classification - Class 2, Special Controls

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
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 - DXQ Blood Pressure Cuff

All 87
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K942777.
BIG BEN SQUARE, BIG BEN ROUND
K972301 · Rudolf Riester GmbH & Co. KG · Sep 1997
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
K962655 · American Diagnostic Corp. · Jan 1997
DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF
K953952 · Deroyal Industries, Inc. · Sep 1995
HAND ANEROID SPHYGMOMANOMETER
K940493 · Welch Allyn, Inc. · Jul 1994
RI-MED
K925297 · Rudolf Riester GmbH & Co. KG · Jan 1994
BLOOD PRESSURE CUFFS
K912638 · Vital Signs, Inc. · Jul 1991