Cleared Special

K030917 - GEM

Also marketed or referenced as:
HAWK EAGLE MODELS 004110, 0044120, 004130

K030917 is an FDA 510(k) clearance for GEM, manufactured by Collins Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Special 510(k) pathway after a 51-day FDA review.

K030917 · Collins Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
51d
Days
Class 2
Risk

K030917 is an FDA 510(k) clearance for the GEM. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Collins Medical, Inc. (Braintree, US). The FDA issued a Cleared decision on May 14, 2003 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K030917

510(k) Number K030917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2003
Decision Date May 14, 2003
Days to Decision 51 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 140d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZG Spirometer, Diagnostic

All 196
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K030917.
FLOSENSE II, MODEL 29-8040
K033939 · Sdi Diagnostics, Inc. · Jan 2004
SPIROTEL, MODEL 29-1020
K031643 · Sdi Diagnostics, Inc. · Dec 2003
MICROLAB SPIROMETER
K031102 · Micro Direct, Inc. · Dec 2003
IQTEQ SPIROMETER
K020102 · Iqteq Development · Mar 2003
GEM, MODEL 004110
K030464 · Collins Medical, Inc. · Mar 2003
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
K023225 · Puritan Bennett Corp. · Dec 2002
K030917 · GEM
Download PDF FDA Summary Collins Medical, Inc.