Cleared Traditional

K880704 - CERULLO SUCTION REGULATOR

K880704 is an FDA 510(k) clearance for CERULLO SUCTION REGULATOR, manufactured by Aesculap Instruments Corp.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K880704 · Aesculap Instruments Corp. · General Hospital
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Mar 1988
Decision
36d
Days
Class 2
Risk

K880704 is an FDA 510(k) clearance for the CERULLO SUCTION REGULATOR. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Aesculap Instruments Corp. (Burlingame, US). The FDA issued a Cleared decision on March 29, 1988 after a review of 36 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 Aesculap Instruments Corp. devices

FDA 510(k) Submission Details - K880704

510(k) Number K880704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1988
Decision Date March 29, 1988
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

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 58
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K880704.
VAC-RITE
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K881252 · Deknatel, Inc. · Jun 1988
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K873489 · J. H. Emerson Co. · Dec 1987
OHMEDA POSI-PULSE SUCTION UNIT
K861261 · Ohmeda Medical · May 1986
BOEHRINGER LABORATORIES SUCTION INTERMITTOR
K853095 · Boehringer Laboratories · Aug 1985