Cleared Traditional

K133051 - PULMONE MINIBOX PFT TM

K133051 is an FDA 510(k) clearance for PULMONE MINIBOX PFT TM, manufactured by Pulmone Advanced Medical Devices, Ltd.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K133051 · Pulmone Advanced Medical Devices, Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
217d
Days
Class 2
Risk

K133051 is an FDA 510(k) clearance for the PULMONE MINIBOX PFT TM. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Pulmone Advanced Medical Devices, Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on May 2, 2014 after a review of 217 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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.

FDA 510(k) Submission Details - K133051

510(k) Number K133051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2013
Decision Date May 02, 2014
Days to Decision 217 days
Submission Type Traditional
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
77d slower than avg
Panel avg: 140d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01952431 Completed Interventional Industry-sponsored

Measurement and Evaluation of Total Lung Capacity (TLC) in the Field of Pulmonary Functional Testing (PFT)

100
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied TLC in Patients With and Without Respiratory System Disease
Study design Crossover
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Mordechai Yigla, MD
Sponsor PulmOne Advanced Medical Devices, Ltd. (industry)
Started 2013-04-01 → Primary completion 2013-09-01
Primary outcome
Total Lung Capacity (TCL)
Study completed - no results published. This trial concluded in 2013 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - BZC Calculator, Pulmonary Function Data

All 53
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