Cleared Traditional

K241202 - Electric nasal aspirator (HTD2601US) (FDA 510(k) Clearance)

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

K241202 · Hetaida Technology Co., Ltd. · Ear, Nose, Throat device
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Jul 2024
Decision
62d
Days
Class 2
Risk

K241202 is an FDA 510(k) clearance for the Electric nasal aspirator (HTD2601US). Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Hetaida Technology Co., Ltd. (Dongguan City, CN). The FDA issued a Cleared decision on July 1, 2024 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 878.4780 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hetaida Technology Co., Ltd. devices

Submission Details

510(k) Number K241202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2024
Decision Date July 01, 2024
Days to Decision 62 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
27d faster than avg
Panel avg: 89d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 - BTA Pump, Portable, Aspiration (manual Or Powered)

All 154
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K241202.
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
K253107 · Shenzhen Dongjiang Technology Co., Ltd. · Apr 2026
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
K260147 · Shenzhen Kingboom Technology Co., Ltd. · Mar 2026
Baby Nasal Aspirator (BN002)
K251450 · Shenzhen Desida Technology Co., Ltd. · Jun 2025
Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
K244033 · Shenzhen Desida Technology Co., Ltd. · May 2025
AIRO Suction Unit (AIRO-01)
K251101 · Cro, LLC · Apr 2025
Electric Nasal Aspirator (BC026, BC025, BC023)
K250697 · Shenzhen Kingboom Technology Co., Ltd. · Apr 2025