Cleared Traditional

K980951 - ONEFLOW

K980951 is an FDA 510(k) clearance for ONEFLOW, manufactured by Sti Medical. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 714-day FDA review.

K980951 · Sti Medical · Anesthesiology device
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Feb 2000
Decision
714d
Days
Class 2
Risk

K980951 is an FDA 510(k) clearance for the ONEFLOW. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Sti Medical (Cedar Grove, US). The FDA issued a Cleared decision on February 25, 2000 after a review of 714 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1860 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Sti Medical devices

FDA 510(k) Submission Details - K980951

510(k) Number K980951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1998
Decision Date February 25, 2000
Days to Decision 714 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
574d slower than avg
Panel avg: 140d · This submission: 714d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZH Device Classification - Class 2, Special Controls

Product Code BZH Meter, Peak Flow, Spirometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1860
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 - BZH Meter, Peak Flow, Spirometry

All 37
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K980951.
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
K040723 · Microlife Intellectual Property GmbH · Jun 2004
MODIFICATION TO TRUPEAK PEAK FLOW METER
K031514 · Monaghan Medical Corp. · May 2003
TRUEZONE PEAK FLOW METER
K023097 · Monaghan Medical Corp. · Mar 2003
MODIFICATION TO TRUZONE PEAK FLOW METER
K991212 · Monaghan Medical Corp. · Jul 1999
AIRZONE PEAK FLOWMETER
K982334 · Clement Clarke Intl., Ltd. · Jan 1999
ACCUTRAX, MODEL EPF840
K982995 · Korr Medical Technologies, Inc. · Dec 1998