Cleared Traditional

K884543 - LSP DEMAND INHALATOR VALVE MODEL SPOO68...

K884543 is an FDA 510(k) clearance for LSP DEMAND INHALATOR VALVE MODEL SPOO68..., manufactured by Sechrist Industries, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K884543 · Sechrist Industries, Inc. · Anesthesiology device
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Dec 1988
Decision
43d
Days
Class 2
Risk

K884543 is an FDA 510(k) clearance for the LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on December 13, 1988 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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: 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 Sechrist Industries, Inc. devices

FDA 510(k) Submission Details - K884543

510(k) Number K884543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1988
Decision Date December 13, 1988
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 140d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 32
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K884543.
NON-REBREATHING 'T' (BE 117)
K973066 · Instrumentation Industries, Inc. · Feb 1998
ONE-WAY VALVE (WITH CONNECTOR)
K970780 · Instrumentation Industries, Inc. · Sep 1997
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955634 · Boston Medical Products, Inc. · Jun 1996
NON-REBREATHING TEE PIECE (NRTP)
K883988 · Dhd Medical Products Div. Diemolding Corp. · Oct 1988
CARHILL ONE-WAY RESUSCITATION VALVE
K864681 · Life Design Systems, Inc. · May 1987
NO. 1552, VALVED VENTI-COMP
K870895 · Hudson Oxygen Therapy Sales Co. · May 1987