Cleared Traditional

K852824 - PMA PRESSURE MONITOR

K852824 is an FDA 510(k) clearance for PMA PRESSURE MONITOR, manufactured by Ferguson Medical. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K852824 · Ferguson Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
155d
Days
Class 2
Risk

K852824 is an FDA 510(k) clearance for the PMA PRESSURE MONITOR. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on December 3, 1985 after a review of 155 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ferguson Medical devices

FDA 510(k) Submission Details - K852824

510(k) Number K852824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1985
Decision Date December 03, 1985
Days to Decision 155 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 140d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAP Device Classification - Class 2, Special Controls

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 48
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K852824.
MODIFIED BAROMED BREATHING PRESSURE MONITOR
K861720 · Draeger Medical, Inc. · May 1986
SECHRIST AIRWAY PRESSURE MONITOR MODEL 600
K861330 · Sechrist Industries, Inc. · Apr 1986
VENTILATOR PRESSURE ALARM MODEL VPA-100
K854934 · Respiratory Support Products, Inc. · Dec 1985
AN PRESSURE MONITOR
K852826 · Ferguson Medical · Dec 1985
AIRWAY PRESSURE MONITOR
K840420 · Respiratory Support Products, Inc. · Apr 1984
DRAGER BAROMED
K840279 · Draeger Medical, Inc. · Mar 1984