Cleared Abbreviated

K001412 - PM 1800 CONSERVING DEVICE

K001412 is an FDA 510(k) clearance for PM 1800 CONSERVING DEVICE, manufactured by Precision Medical, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Abbreviated 510(k) pathway after a 320-day FDA review.

K001412 · Precision Medical, Inc. · Anesthesiology device
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Mar 2001
Decision
320d
Days
Class 2
Risk

K001412 is an FDA 510(k) clearance for the PM 1800 CONSERVING DEVICE. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on March 20, 2001 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Precision Medical, Inc. devices

FDA 510(k) Submission Details - K001412

510(k) Number K001412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2000
Decision Date March 20, 2001
Days to Decision 320 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 140d · This submission: 320d
Pathway characteristics
Standards-based clearance path.

NFB Device Classification - Class 2, Special Controls

Product Code NFB Conserver, Oxygen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - NFB Conserver, Oxygen

All 17
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K001412.
EOCD
K041568 · Respironics, Inc. · Jul 2004
EASY PULSE II OXYGEN CONSERVER
K032018 · Precision Medical, Inc. · Aug 2003
AIRLIFE DEMAND NASAL CANNULA
K023673 · Allegiance Healthcare Corp. · May 2003
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · Invacare Corp. · Oct 2000
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K990678 · Salter Labs · May 1999
PULSE DOSE SERIES
K961126 · Devilbiss Health Care, Inc. · Oct 1996