Cleared Traditional

K884320 - PROPAQ 106(TM)

K884320 is an FDA 510(k) clearance for PROPAQ 106(TM), manufactured by Protocol Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K884320 · Protocol Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
75d
Days
Class 2
Risk

K884320 is an FDA 510(k) clearance for the PROPAQ 106(TM). Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Protocol Systems, Inc. (Beaverton, US). The FDA issued a Cleared decision on December 27, 1988 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 - K884320

510(k) Number K884320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1988
Decision Date December 27, 1988
Days to Decision 75 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
50d faster than avg
Panel avg: 125d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 324
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K884320.
MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM
K882609 · Waltham Div. Hewlett Packard · Jan 1989
MINIMON 7134B PATIENT MONITOR
K883069 · Kontron Instruments, Inc. · Jan 1989
MINIMON 7136B PATIENT MONITOR
K883109 · Kontron, Inc. · Jan 1989
RIGEL MODEL MULTICARE 409
K875160 · Rigel Medical Electronics, Inc. · Jun 1988
MONITRON SYSTEM
K874148 · American Health Products, Inc. · Jun 1988
RM-301 PATIENT MONITOR
K880498 · Ppg Industries, Inc. · May 1988
K884320 · PROPAQ 106(TM)
Download PDF Protocol Systems, Inc.