Cleared Traditional

K831348 - FLUID ADMIN. SET AFS-1C

K831348 is the FDA 510(k) clearance for FLUID ADMIN. SET AFS-1C by Linton Biomed Corp.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K831348 · Linton Biomed Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1983
Decision
32d
Days
Class 2
Risk

K831348 is an FDA 510(k) clearance for the FLUID ADMIN. SET AFS-1C. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Linton Biomed Corp. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1983 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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: 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 Linton Biomed Corp. devices

Submission Details

510(k) Number K831348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1983
Decision Date May 27, 1983
Days to Decision 32 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 125d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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.

Regulatory Peers - DRS Transducer, Blood-pressure, Extravascular

All 83
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K831348.
TRANSDUCER DOME DS106
K833096 · Sorensen Research · Nov 1983
DISP. TRANSDUCER W/MONITORING KIT TRANS
K831506 · Sorensen Research · Aug 1983
DISPOSABLE PRESSURE TRANSDUCER#14004195
K831698 · Norton Performance Plastics Corp. · Aug 1983
DISPOSABLE PRESSURE TRANSDUCER
K830210 · American Pharmaseal Div. Ahsc · Apr 1983
USCI ELECTRONIC MANOMETER
K830093 · C.R. Bard, Inc. · Jan 1983
DISPOSABLE TRANSDUCER & ACCESSORIES
K822507 · Gould, Inc. · Sep 1982