Cleared Traditional

K810838 - NEONATAL BLOOD PRESSURE CUFF

K810838 is the FDA 510(k) clearance for NEONATAL BLOOD PRESSURE CUFF by Invivo Research Labs, Inc.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K810838 · Invivo Research Labs, Inc. · Cardiovascular device
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Apr 1981
Decision
7d
Days
Class 2
Risk

K810838 is an FDA 510(k) clearance for the NEONATAL BLOOD PRESSURE CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Invivo Research Labs, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 3, 1981 after a review of 7 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 Invivo Research Labs, Inc. devices

Submission Details

510(k) Number K810838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1981
Decision Date April 03, 1981
Days to Decision 7 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 70
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K810838.
CONPHAR, WALL ANEROID SPHYGMOMANOMETER
K813303 · Conphar, Inc. · Jan 1982
THIGH CUFF: X-LARGE CUFF
K813323 · Abco Dealers, Inc. · Dec 1981
TRONZO HIP
K812946 · Biomet, Inc. · Nov 1981
CONPHAR DELUXE ANEROID SPHYGMOMANOMETER
K801186 · Conphar, Inc. · Jun 1980
CONPHAR DESK TOP MERCURY SPHYGMOMAN
K801188 · Conphar, Inc. · Jun 1980
CONPHAR WALL MODEL MERCURY SPHYGMOMAN.
K801182 · Conphar, Inc. · Jun 1980