Cleared Traditional

PCM 2000 (K970448) - FDA 510(k) Clearance

Also marketed or referenced as:
ISOLAIR APR MODEL 2735

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970448 · Tecnol Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
83d
Days
Class 2
Risk

K970448 is an FDA 510(k) clearance for the PCM 2000. Classified as Respirator, Surgical (product code MSH), Class II - Special Controls.

Submitted by Tecnol Medical Products, Inc. (Fort Worth, US). The FDA issued a Cleared decision on April 30, 1997 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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: 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 Tecnol Medical Products, Inc. devices

Submission Details

510(k) Number K970448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1997
Decision Date April 30, 1997
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSH Respirator, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
Definition A Surgical N95 Respirator Or N95 Filtering Facepiece Respirator Is Not Exempt If It Is Intended To Prevent Specific Diseases Or Infections, Or It Is Labeled Or Otherwise Represented As Filtering Surgical Smoke Or Plumes, Filtering Specific Amounts Of Viruses Or Bacteria, Reducing The Amount Of And/or Killing Viruses, Bacteria, Or Fungi, Or Affecting Allergenicity, Or It Contains coating Technologies Unrelated To Filtration (e.g., To Reduce And Or Kill Microorganisms).  surgical N95 Respirators And N95 Filtering Facepiece Respirators Are Exempt From The Premarket Notification Procedures Subject To 21 Cfr 878.9 And The Conditions For Exemption Identified In 21 Cfr 878.4040(b)(1).
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.