Cleared Traditional

K894700 - TYPE PDU/CDU 9040 (SYSTEM ATHENA)

K894700 is an FDA 510(k) clearance for TYPE PDU/CDU 9040 (SYSTEM ATHENA), manufactured by S & W Medico Teknik. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K894700 · S & W Medico Teknik · Cardiovascular device
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Oct 1989
Decision
70d
Days
Class 2
Risk

K894700 is an FDA 510(k) clearance for the TYPE PDU/CDU 9040 (SYSTEM ATHENA). Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on October 2, 1989 after a review of 70 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.

View all S & W Medico Teknik devices

FDA 510(k) Submission Details - K894700

510(k) Number K894700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date October 02, 1989
Days to Decision 70 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
55d faster than avg
Panel avg: 125d · This submission: 70d
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 201
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K894700.
ERGOMED 840/ERGOMED 840L
K885085 · Burdick Corp. · Oct 1989
MODEL DS-504 DYNASCOPE PATIENT MONITOR
K893405 · Fukuda Denshi USA, Inc. · Oct 1989
TYPE 9140 (SYSTEM ATHENA)
K894699 · S & W Medico Teknik · Oct 1989
HORIZON CENTRAL STATION
K892066 · Mennen Medical, Inc. · Jun 1989
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S
K892006 · Healthdyne, Inc. · May 1989
TYPE 9210 ECG SYSTEM ATHENA
K884117 · S & W Medico Teknik · Apr 1989