Cleared Traditional

K971981 - LS SERIES 200 FLOVISION SYSTEM

K971981 is an FDA 510(k) clearance for LS SERIES 200 FLOVISION SYSTEM, manufactured by Systam. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 572-day FDA review.

K971981 · Systam · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
572d
Days
Class 2
Risk

K971981 is an FDA 510(k) clearance for the LS SERIES 200 FLOVISION SYSTEM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Systam (Elfers, US). The FDA issued a Cleared decision on December 22, 1998 after a review of 572 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Systam devices

FDA 510(k) Submission Details - K971981

510(k) Number K971981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1997
Decision Date December 22, 1998
Days to Decision 572 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
432d slower than avg
Panel avg: 140d · This submission: 572d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 247
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K971981.
SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER
K992986 · Salter Labs · Sep 1999
SALTER LABS PEP DEVICE
K991788 · Salter Labs · Aug 1999
AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
K982722 · Ambu, Inc. · Apr 1999
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
K983403 · Salter Labs · Dec 1998
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D
K981249 · Instrumentation Industries, Inc. · Nov 1998
MYSTIQUE ULTRASONIC NEBULIZER
K983002 · Airsep Corp. · Oct 1998