Cleared Traditional

K853785 - SERIES 2000 MEDS MASK

K853785 is an FDA 510(k) clearance for SERIES 2000 MEDS MASK, manufactured by Med Systems. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K853785 · Med Systems · Anesthesiology device
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Dec 1985
Decision
84d
Days
Class 1
Risk

K853785 is an FDA 510(k) clearance for the SERIES 2000 MEDS MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Med Systems (Santa Monica, US). The FDA issued a Cleared decision on December 3, 1985 after a review of 84 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 Med Systems devices

FDA 510(k) Submission Details - K853785

510(k) Number K853785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1985
Decision Date December 03, 1985
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
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 29
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K853785.
MP-XML DISPOSABLE FACE MASK
K862782 · Medipart Jerry Alexander · Aug 1986
MP-XMV DISPOSABLE FACE MASK
K862783 · Medipart Jerry Alexander · Aug 1986
MP-XMO DISPOSABLE FACE MASK
K862784 · Medipart Jerry Alexander · Aug 1986
MEDIPART FACE MASK & FILTER MP-30XM
K844493 · Medipart Jerry Alexander · Dec 1984
MEDIPART FACE MASK MP-XM
K844494 · Medipart Jerry Alexander · Dec 1984
CUSHION-FLEX TM
K843169 · Life Design Systems, Inc. · Aug 1984