Chrysalis Intelligence · Product Codes · BTA

BTA · Unclassified

26 clearances · 19 unique sponsors

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Device class
—
Regulation —
Total clearances
26
2020-09-03 → 2026-05-26
Last 12 months
6
Unique sponsors
19
Classification details
Medical specialty
—
Review panel
—
Regulation number
—
Implant
—
Life-sustain / support
—
GMP exempt
—
Third-party review
—
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Shenzhen Kingboom Technology Co., Ltd. 3 2 2026-05-12
Shenzhen Desida Technology Co., Ltd. 3 0 2025-06-06
Somavac Medical Solutions, Inc. 2 0 2023-05-12
Geon Corporation 2 0 2025-02-04
Shenzhen Root Innovation Technology Co., Ltd. 2 2 2026-05-26
Dongguanshi Yiyingmei Technology Co., Ltd. 1 0 2024-11-19
Aroa Biosurgery , Ltd. 1 0 2023-04-07
Shenzhen Dongjiang Technology Co., Ltd. 1 1 2026-04-14
Gi Supply, Inc. 1 0 2023-04-19
Anest Iwata Sparmax Co., Ltd. 1 0 2020-09-03
Atmos Medizintechnik GmbH & Co. KG 1 0 2025-03-07
Cro, LLC 1 0 2025-04-26
Avita Corporation 1 0 2024-12-31
Medline Industries, Inc. 1 0 2021-05-04
Shenzhen Xinlianfeng Technology Co.,Ltd 1 0 2022-10-20
Drw Medical 1 0 2022-09-16
Hetaida Technology Co., Ltd. 1 0 2024-07-01
Shenzhen HugeMed Medical Technical Development Co., Ltd. 1 1 2026-05-14
Anoxia Medical, Inc. 1 0 2024-02-22
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
E0601 HCPCS Continuous positive airway pressure (cpap) device ✓ CMS-verified description Medium Continuous positive airway pressure (CPAP) device; portable aspiration pump DME code
97161 CPT — Low Physical therapy evaluation; aspiration pump used as adjunctive respiratory therapy
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-26 K253629 Shenzhen Root Innovation Technology Co., Ltd. Momcozy Nasal Aspirator (BN007)
2026-05-15 K260134 Shenzhen Root Innovation Technology Co., Ltd. Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
2026-05-14 K260892 Shenzhen HugeMed Medical Technical Development Co., Ltd. Suction Pump (SU-90)
2026-05-12 K260473 Shenzhen Kingboom Technology Co., Ltd. Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)
2026-04-14 K253107 Shenzhen Dongjiang Technology Co., Ltd. Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
2026-03-13 K260147 Shenzhen Kingboom Technology Co., Ltd. Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
2025-06-06 K251450 Shenzhen Desida Technology Co., Ltd. Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)
2025-05-16 K244033 Shenzhen Desida Technology Co., Ltd. Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
2025-04-26 K251101 Cro, LLC AIRO Suction Unit (AIRO-01)
2025-04-23 K250697 Shenzhen Kingboom Technology Co., Ltd. Electric Nasal Aspirator (BC026, BC025, BC023)
2025-03-07 K241799 Atmos Medizintechnik GmbH & Co. KG ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C
2025-02-04 K243138 Geon Corporation Geon (S2) Nasal Aspirator
2024-12-31 K241852 Avita Corporation Nasal Aspirator (NS 13)
2024-11-19 K242028 Dongguanshi Yiyingmei Technology Co., Ltd. Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
2024-07-01 K241202 Hetaida Technology Co., Ltd. Electric nasal aspirator (HTD2601US)
2024-03-20 K233901 Shenzhen Desida Technology Co., Ltd. Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)
2024-02-22 K232831 Anoxia Medical, Inc. Quiver Aspiration Pump
2023-05-12 K231063 Somavac Medical Solutions, Inc. SOMAVAC® 100 Sustained Vacuum System
2023-04-19 K221042 Gi Supply, Inc. Renova RP Centesis Pump
2023-04-07 K223373 Aroa Biosurgery , Ltd. Enivo™
2023-02-02 K220126 Geon Corporation Geonic Nasal Aspirator, Geonic Nasal Cleaner
2022-10-20 K222547 Shenzhen Xinlianfeng Technology Co.,Ltd Electric nasal aspirator
2022-10-19 K222856 Somavac Medical Solutions, Inc. SOMAVAC 100 Sustained Vacuum System
2022-09-16 K221676 Drw Medical Exsalta
2021-05-04 K203135 Medline Industries, Inc. Medline Vacu-line Suction Aspirator
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence