Cleared Traditional

Single-Use Flexible Rhinolaryngoscope (K221581) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221581 · Hunan Vathin Medical Instrument Co., Ltd. · Ear, Nose, Throat device
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Nov 2022
Decision
170d
Days
Class 2
Risk

K221581 is an FDA 510(k) clearance for the Single-Use Flexible Rhinolaryngoscope. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Hunan Vathin Medical Instrument Co., Ltd. (Xiangtan, CN). The FDA issued a Cleared decision on November 18, 2022 after a review of 170 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Hunan Vathin Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K221581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2022
Decision Date November 18, 2022
Days to Decision 170 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 89d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOB Nasopharyngoscope (flexible Or Rigid)

All 66
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K221581.
PatCom Distal Chip Endoscope
K222587 · H&A Mui Enterprises, Inc. · Jul 2023
Single-use Flexible Rhinolaryngoscope
K230536 · Hunan Vathin Medical Instrument Co., Ltd. · Jun 2023
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
K221660 · Olympus Medical Systems Corp. · Dec 2022
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
K220465 · Pentax of America, Inc. · Nov 2022
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
K221638 · Olympus Medical Systems Corp. · Sep 2022
ENT Nasopharyngoscope and Accessories
K214050 · Medimaging Integrated Solution, Inc (Miis) · Jul 2022