Cleared Traditional

K232520 - Fingertip Pulse Oximeter

K232520 is an FDA 510(k) clearance for Fingertip Pulse Oximeter, manufactured by Shenzhen Smallsignal Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 461-day FDA review.

K232520 · Shenzhen Smallsignal Technology Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
461d
Days
Class 2
Risk

K232520 is an FDA 510(k) clearance for the Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, .... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Smallsignal Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 21, 2024 after a review of 461 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Shenzhen Smallsignal Technology Co., Ltd. devices

FDA 510(k) Submission Details - K232520

510(k) Number K232520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2023
Decision Date November 21, 2024
Days to Decision 461 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
321d slower than avg
Panel avg: 140d · This submission: 461d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K232520.
Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
K233956 · Taiwan Aulisa Medical Devices Technologies, Inc. · Jan 2025
Pulse Oximeter (FS20P)
K243049 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Jan 2025
Evie Med Ring
K241090 · Movano Inc. Dba Movano Health · Nov 2024
Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)
K240092 · Shenzhen Yimi Life-Technology Co., Ltd. · Oct 2024
Belun Ring BLR-200 (BLR-200)
K234110 · Belun Technology Company Limited · Oct 2024
Pulse Oximeter (WS20A)
K240808 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Oct 2024