Cleared Traditional

K231561 - Pulmonary Function Tester

K231561 is an FDA 510(k) clearance for Pulmonary Function Tester, manufactured by Guangzhou Homesun Medical Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K231561 · Guangzhou Homesun Medical Technology Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
266d
Days
Class 2
Risk

K231561 is an FDA 510(k) clearance for the Pulmonary Function Tester, Model: A9. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Guangzhou Homesun Medical Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 21, 2024 after a review of 266 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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 Guangzhou Homesun Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K231561

510(k) Number K231561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2023
Decision Date February 21, 2024
Days to Decision 266 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
126d slower than avg
Panel avg: 140d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 Consultant

Feiying Drug & Medical Consulting Technical Service Group
Tracy Che

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTY Calculator, Predicted Values, Pulmonary Function

All 17
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K231561.
Ascent Cardiorespiratory Diagnostic Software
K242809 · Medical Graphics Corporation · Oct 2024
SpiroSphere, SpiroSphereECG, CardioSphere
K223629 · Eresearchtechnology GmbH · May 2024
Virtus Metabolic Monitor
K222982 · Virtus Technology Aps · Jun 2023
Model 9100 PFT/DICO
K221030 · Vitalograph (Ireland) , Ltd. · Jul 2022
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
K202754 · Eresearchtechnology GmbH · Jan 2021
Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
K190800 · Cosmed Srl · Feb 2020