Cleared Traditional

K870578 - NIGHTWATCH(TM) SYSTEM

K870578 is an FDA 510(k) clearance for NIGHTWATCH(TM) SYSTEM, manufactured by Buckman Co., Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K870578 · Buckman Co., Inc. · Cardiovascular device
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Jun 1987
Decision
139d
Days
Class 2
Risk

K870578 is an FDA 510(k) clearance for the NIGHTWATCH(TM) SYSTEM. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on June 29, 1987 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 Buckman Co., Inc. devices

FDA 510(k) Submission Details - K870578

510(k) Number K870578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1987
Decision Date June 29, 1987
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 119
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K870578.
RHYTHMSCAN HR HOLTER RECORDER
K882366 · Brentwood Instruments, Inc. · Aug 1988
MODEL 492 SSR (TM) RECORDER
K874313 · Del Mar Avionics · Feb 1988
MODIFIED MODEL 9431 TELETRACE TRANSMITTER
K872246 · Medtronic Vascular · Jul 1987
MODEL 509A PHYSIOCORDER AMBULATORY RECORDER
K854269 · Del Mar Avionics · Apr 1986
MODEL MR-30 HOLTER RECORDER
K860181 · Oxford Medilog, Inc. · Feb 1986
MODEL MR-35 HOLTER RECORDER
K860182 · Oxford Medilog, Inc. · Feb 1986