Cleared Traditional

K935553 - MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP

K935553 is an FDA 510(k) clearance for MULLY SUCTION STRAIGHT WITH FINGERTIP/W..., manufactured by Puritas Health Care, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K935553 · Puritas Health Care, Inc. · Anesthesiology device
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Jan 1994
Decision
58d
Days
Class 1
Risk

K935553 is an FDA 510(k) clearance for the MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on January 14, 1994 after a review of 58 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 Puritas Health Care, Inc. devices

FDA 510(k) Submission Details - K935553

510(k) Number K935553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1993
Decision Date January 14, 1994
Days to Decision 58 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 140d · This submission: 58d
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 63
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K935553.
KENDALL MODU-VAC CLOSED SUCTION SYSTEM
K944251 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1994
TRACHEAL SUCTION CATHETER
K935600 · Puritas Health Care, Inc. · May 1994
SUCTION SET, TRACHAEL
K935583 · Puritas Health Care, Inc. · Apr 1994
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K934723 · Sherwood Medical Co. · Nov 1993
ARGYLE ASPIR-FLEX SUCTION CATHETER
K925556 · Sherwood Medical Co. · Jul 1993
DYNAREX SUCTION CATHETERS & KITS
K922843 · Dynarex Corp. · Jan 1993