Cleared Traditional

K881291 - AIR PLETHYSMOGRAPH MODEL APG-1000

K881291 is the FDA 510(k) clearance for AIR PLETHYSMOGRAPH MODEL APG-1000 by Aci Medical, Inc.. It is a Class 2 Cardiovascular device (product code DSB) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K881291 · Aci Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
200d
Days
Class 2
Risk

K881291 is an FDA 510(k) clearance for the AIR PLETHYSMOGRAPH MODEL APG-1000. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Aci Medical, Inc. (Sun Valley, US). The FDA issued a Cleared decision on October 14, 1988 after a review of 200 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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 Aci Medical, Inc. devices

Submission Details

510(k) Number K881291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date October 14, 1988
Days to Decision 200 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 125d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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.