Cleared Traditional

K883384 - TS1000 SUCTION TIP

K883384 is an FDA 510(k) clearance for TS1000 SUCTION TIP, manufactured by M.D. Engineering, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K883384 · M.D. Engineering, Inc. · Anesthesiology device
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Nov 1988
Decision
85d
Days
Class 1
Risk

K883384 is an FDA 510(k) clearance for the TS1000 SUCTION TIP. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by M.D. Engineering, Inc. (Hayward, US). The FDA issued a Cleared decision on November 2, 1988 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - 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 M.D. Engineering, Inc. devices

FDA 510(k) Submission Details - K883384

510(k) Number K883384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date November 02, 1988
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

BSY Device Classification - Class 1, General Controls

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
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 - BSY Catheters, Suction, Tracheobronchial

All 70
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K883384.
MUCOUS TRAP
K896560 · Westmark, Sterile Packing Systems, Inc. (Sps) · Jan 1990
KENDALL CURITY SUCTION CATHETERS
K892441 · The Kendal Co. · May 1989
SUCTION CONTROL VALVE
K892343 · Concord/Portex · Apr 1989
RESPIRONICS SUCTIONEASY
K882017 · Respironics, Inc. · Jul 1988
STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407
K875058 · Busse Hospital Disposables, Inc. · Feb 1988
SAFETY SHIELD SUCTION CATHETER
K873810 · Ballard Medical Products · Dec 1987