Cleared Traditional

K890795 - RESPIRONICS SEALEASY II

K890795 is an FDA 510(k) clearance for RESPIRONICS SEALEASY II, manufactured by Respironics, Inc.. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K890795 · Respironics, Inc. · Anesthesiology device
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Apr 1989
Decision
62d
Days
Class 1
Risk

K890795 is an FDA 510(k) clearance for the RESPIRONICS SEALEASY II. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on April 20, 1989 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5550 - 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 Respironics, Inc. devices

FDA 510(k) Submission Details - K890795

510(k) Number K890795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1989
Decision Date April 20, 1989
Days to Decision 62 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 140d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

BSJ Device Classification - Class 1, General Controls

Product Code BSJ Mask, Gas, Anesthetic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5550
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BSJ Mask, Gas, Anesthetic

All 21
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K890795.
ANESTHESIA FACE MASK
K953295 · Mallinckrodt Medical · Aug 1995
AMBU DISPOSABLE FACE MASK
K932014 · Ambu, Inc. · Jun 1993
MODIFIED CUSHION-FLEX(TM)
K890108 · Life Design Systems, Inc. · Jan 1989
CUSHION FLEX(TM)
K884387 · Life Design Systems, Inc. · Nov 1988
MP-XMM DISPOSABLE FACE MASK
K862781 · Medipart Jerry Alexander · Aug 1986
MP-XML DISPOSABLE FACE MASK
K862782 · Medipart Jerry Alexander · Aug 1986