Cleared Traditional

K983135 - BLOWER/MISTER

K983135 is an FDA 510(k) clearance for BLOWER/MISTER, manufactured by Cardiothoracic Systems, Inc.. The device is a Class 2 General Hospital device with product code FQH cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K983135 · Cardiothoracic Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
66d
Days
Class 2
Risk

K983135 is an FDA 510(k) clearance for the BLOWER/MISTER. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Cardiothoracic Systems, Inc. (Cupertino, US). The FDA issued a Cleared decision on November 13, 1998 after a review of 66 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5475 - 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 Cardiothoracic Systems, Inc. devices

FDA 510(k) Submission Details - K983135

510(k) Number K983135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1998
Decision Date November 13, 1998
Days to Decision 66 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 129d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FQH Device Classification - Class 2, Special Controls

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
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 - FQH Lavage, Jet

All 35
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K983135.
ERBE ERBEJET 2 SYSTEM
K072404 · Erbe USA, Inc. · Oct 2007
ERBE HELIX HYDRO-JET
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HELIX HYDRO-JET
K022613 · Erbe USA, Inc. · Oct 2002
CHASE ANASTOMOSIS VISUALIZATION DEVICE
K974568 · Chase Medical, Inc. · Jan 1998
FLEXVIEW CO2 BLOWER WITH MIST
K973803 · Ethicon Endo-Surgery, Inc. · Dec 1997
CLEARVIEW BLOWER/MISTER
K973485 · Dlp, Inc. · Dec 1997