Cleared Traditional

K854036 - MANUAL VENTILATION ACCESSORY (FDA 510(k) Clearance)

K854036 · Siemens Elema AB · Cardiovascular device
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Oct 1985
Decision
57d
Days
-
Risk

K854036 is an FDA 510(k) clearance for the MANUAL VENTILATION ACCESSORY.

Submitted by Siemens Elema AB (Schaumburg, US). The FDA issued a Cleared decision on October 23, 1985 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. 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 Siemens Elema AB devices

Submission Details

510(k) Number K854036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1985
Decision Date October 23, 1985
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -