Cleared Traditional

K822311 - DISPOSABLE COLLECTION BOTTLE W/TUBING

K822311 is the FDA 510(k) clearance for DISPOSABLE COLLECTION BOTTLE W/TUBING by Ohio Medical Products. It is a Class 2 General Hospital device (product code GCX) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K822311 · Ohio Medical Products · General Hospital
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Aug 1982
Decision
17d
Days
Class 2
Risk

K822311 is an FDA 510(k) clearance for the DISPOSABLE COLLECTION BOTTLE W/TUBING. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on August 20, 1982 after a review of 17 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 Ohio Medical Products devices

Submission Details

510(k) Number K822311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1982
Decision Date August 20, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
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.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 25
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K822311.
ACCURATE MEASUREMENT DEVICE EZ-AMD
K833673 · Sorensen Research · Dec 1983
TALL FLOOR STAND TFS-01
K831939 · Sorensen Research · Jul 1983
PLEUR-EVAC A-4005 SYSTEM
K823037 · Howmedica Corp. · Oct 1982
SPECIMEN COLLECTORS
K822005 · Kelleher Corp. · Jul 1982
THORACIC DRAINAGE SYSTEM
K821023 · Howmedica Corp. · May 1982
SURGICAL SUCTION INSTRUMENTS-DISPOS.
K812845 · Abco Dealers, Inc. · Nov 1981