Cleared Traditional

K832017 - LME BLOOD PRESSURE MONITOR

K832017 is an FDA 510(k) clearance for LME BLOOD PRESSURE MONITOR, manufactured by Litton Medical Electronics. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K832017 · Litton Medical Electronics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1983
Decision
130d
Days
Class 2
Risk

K832017 is an FDA 510(k) clearance for the LME BLOOD PRESSURE MONITOR. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Litton Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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. Standard predicate reliance. 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 Litton Medical Electronics devices

FDA 510(k) Submission Details - K832017

510(k) Number K832017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1983
Decision Date October 31, 1983
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSK Device Classification - Class 2, Special Controls

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 48
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K832017.
PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
K862647 · Ivy Biomedical Systems, Inc. · Aug 1986
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
K860689 · Spacelabs, Inc. · Jul 1986
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
K850879 · Mennen Medical, Inc. · Apr 1985
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · Hewlett-Packard Co. · Oct 1982
MODEL 1100 SPHYGMOMANOMETER
K811208 · Y · May 1981
PERIPHERAL PULSE FUNCTION BLOCKS
K810171 · Honeywell, Inc. · Feb 1981