Cleared Traditional

K854359 - LM2000A SURGICAL SUCTION MONITOR

K854359 is the FDA 510(k) clearance for LM2000A SURGICAL SUCTION MONITOR by Engineering, Inc.. It is a Class 2 General Hospital device (product code KDQ) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K854359 · Engineering, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
125d
Days
Class 2
Risk

K854359 is an FDA 510(k) clearance for the LM2000A SURGICAL SUCTION MONITOR. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Engineering, Inc. (Foster City, US). The FDA issued a Cleared decision on March 3, 1986 after a review of 125 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Engineering, Inc. devices

Submission Details

510(k) Number K854359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date March 03, 1986
Days to Decision 125 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 129d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDQ Bottle, Collection, Vacuum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - KDQ Bottle, Collection, Vacuum

All 31
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K854359.
URESIL THORACIC VENT
K863561 · Uresil Corp. · Sep 1986
T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
K861025 · Boehringer Laboratories · Apr 1986
FILTERED VACUUM SAFETY TRAP BOTTLE
K855074 · Boehringer Laboratories · Mar 1986
COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT
K860023 · Atrium Medical Corp. · Jan 1986
BARD PARKER THORACIC VENT
K854634 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1985
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
K851244 · Cook, Inc. · Nov 1985