Cleared Special

K070532 - SPIROS

K070532 is an FDA 510(k) clearance for SPIROS, manufactured by Icu Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 22-day FDA review.

K070532 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
22d
Days
Class 2
Risk

K070532 is an FDA 510(k) clearance for the SPIROS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 20, 2007 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 - K070532

510(k) Number K070532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2007
Decision Date March 20, 2007
Days to Decision 22 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 1171
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K070532.
SURFLO WINGED INFUSION SET
K070362 · Terumo Europe N.V. · May 2007
PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS
K070430 · Unomedical A/S · Apr 2007
LMT-KATH-S
K062308 · Licher Medizintechnologie GmbH · Mar 2007
REPEATER PUMP II TUBE SETS
K062909 · Baxa Corp. · Mar 2007
ACCU-CHEK ULTRAFLEX INFUSION SET
K070189 · Disetronic Medical Systems AG · Feb 2007
INTUITION INFUSION SETS
K061374 · Unomedical A/S · Jul 2006
K070532 · SPIROS
Download PDF FDA Summary Icu Medical, Inc.