Cleared Traditional

K110316 - INFOSEND GSM

K110316 is an FDA 510(k) clearance for INFOSEND GSM, manufactured by Fisher &Paykel Healthcare , Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K110316 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
197d
Days
Class 2
Risk

K110316 is an FDA 510(k) clearance for the INFOSEND GSM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on August 19, 2011 after a review of 197 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fisher &Paykel Healthcare , Ltd. devices

FDA 510(k) Submission Details - K110316

510(k) Number K110316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2011
Decision Date August 19, 2011
Days to Decision 197 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 140d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 428
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K110316.
TASMAN
K112393 · Resmed, Ltd. · Nov 2011
3B FLEX-LITE
K103434 · 3B Products, LLC · Oct 2011
BABI PLUS INFANT NASAL CANNULA SYSTEM
K110471 · A Plus Medical · Oct 2011
BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
K110383 · A Plus Medical · Aug 2011
EASYFIT SILKGEL NASAL MASK
K110884 · Weinmann Gerate Fur Medizin GmbH + Co. KG · Jul 2011
S8 ASPEN WITH H4I PLUS
K111148 · ResMed Corp · Jun 2011