Cleared Traditional

K820077 - EMERSON THORACIC SUCTION REG. #55-JP

K820077 is an FDA 510(k) clearance for EMERSON THORACIC SUCTION REG. #55-JP, manufactured by J. H. Emerson Co.. The device is a Class 2 General Hospital device with product code KDP cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K820077 · J. H. Emerson Co. · General Hospital
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Jan 1982
Decision
16d
Days
Class 2
Risk

K820077 is an FDA 510(k) clearance for the EMERSON THORACIC SUCTION REG. #55-JP. Classified as Regulator, Vacuum (product code KDP), Class II - Special Controls.

Submitted by J. H. Emerson Co. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1982 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 J. H. Emerson Co. devices

FDA 510(k) Submission Details - K820077

510(k) Number K820077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1982
Decision Date January 28, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 129d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDP Device Classification - Class 2, Special Controls

Product Code KDP Regulator, Vacuum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.