Device class
—
Regulation —
Total clearances
41
2020-01-16 → 2026-07-31
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Itamar Medical , Ltd.
|
5 |
2 |
2026-07-31 |
|
Huxley Medical
|
4 |
2 |
2025-12-10 |
|
Acurable Limited
|
3 |
0 |
2025-03-19 |
|
Onera B.V.
|
3 |
0 |
2025-07-03 |
|
Ectosense NV
|
3 |
0 |
2022-02-24 |
|
Wesper, Inc.
|
3 |
1 |
2026-04-27 |
|
Compumedics Limited
|
2 |
1 |
2025-08-28 |
|
Neurovirtual USA, Inc.
|
2 |
0 |
2020-12-14 |
|
Zephyr Sleep Technologies |
1 |
0 |
2020-08-24 |
|
Snap Diagnostics, LLC |
1 |
0 |
2024-06-04 |
|
Resapp Health |
1 |
0 |
2022-07-05 |
|
Huneo, LLC |
1 |
1 |
2026-07-15 |
|
Pranaq Pte. , Ltd. |
1 |
0 |
2025-02-03 |
|
Withings
|
1 |
0 |
2024-09-06 |
|
Dymedix Diagnostics, Inc. |
1 |
0 |
2020-07-22 |
|
Happy Health, Inc. |
1 |
0 |
2025-06-18 |
|
Dormotech Medical, Ltd. |
1 |
0 |
2025-01-08 |
|
Belun Technology Company Limited
|
1 |
0 |
2023-02-23 |
|
Vivaquant, Inc. Dba Rhythm Express |
1 |
1 |
2026-06-22 |
|
Ensodata |
1 |
0 |
2024-02-09 |
|
Cadwell Industries, Inc.
|
1 |
0 |
2024-12-18 |
|
Sibel, Inc.
|
1 |
0 |
2022-07-11 |
|
Largan Medical Co., Ltd.
|
1 |
0 |
2024-07-26 |
|
Bresotec, Inc. |
1 |
0 |
2022-12-21 |
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.
| Code | Type | Description | Confidence | Rationale |
| 94002 |
CPT
|
— |
Medium
|
Ventilation assist and portable equipment, rental |
| E0607 |
HCPCS
|
Home blood glucose monitor ✓ CMS-verified description |
Medium
|
Home ventilator interface (exhalation port, valve, multi-purpose); per 1 each |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-07-31 |
K254042 |
Itamar Medical , Ltd.
|
WatchPAT SW |
| 2026-07-15 |
K260050 |
Huneo, LLC
|
WRAP System |
| 2026-06-22 |
K253148 |
Vivaquant, Inc. Dba Rhythm Express
|
RX-1 Sleep |
| 2026-04-27 |
K252628 |
Wesper, Inc.
|
CASSIE |
| 2025-12-10 |
K252497 |
Huxley Medical
|
SANSA HSAT |
| 2025-10-29 |
K250882 |
Huxley Medical
|
SANSA HSAT |
| 2025-09-05 |
K250460 |
Itamar Medical , Ltd.
|
WatchPAT400 (WP400) |
| 2025-08-28 |
K252383 |
Compumedics Limited
|
Somfit D |
| 2025-07-03 |
K243220 |
Onera B.V.
|
Onera STS 2 (ONERA STS 2) |
| 2025-06-18 |
K242224 |
Happy Health, Inc.
|
Happy Health Home Sleep Test |
| 2025-03-19 |
K243092 |
Acurable Limited
|
AcuPebble Ox (200) |
| 2025-02-03 |
K243268 |
Pranaq Pte. , Ltd.
|
TipTraQ (TTQ001) |
| 2025-01-28 |
K244027 |
Huxley Medical
|
SANSA HSAT |
| 2025-01-08 |
K242290 |
Dormotech Medical, Ltd.
|
DormoTech NLab |
| 2024-12-18 |
K242424 |
Cadwell Industries, Inc.
|
Bluebird Single-Use Respiratory Effort Belt |
| 2024-09-06 |
K231667 |
Withings
|
Withings Sleep Rx |
| 2024-07-26 |
K233501 |
Largan Medical Co., Ltd.
|
LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) |
| 2024-07-15 |
K240285 |
Huxley Medical
|
Huxley SANSA Home Sleep Apnea Test (1000-00) |
| 2024-06-04 |
K240100 |
Snap Diagnostics, LLC
|
SAM Model 9-10000 |
| 2024-02-09 |
K231355 |
Ensodata
|
Aurora |
| 2023-11-30 |
K231546 |
Compumedics Limited
|
Somfit |
| 2023-08-18 |
K223573 |
Onera B.V.
|
Onera Sleep Test System (Onera STS) |
| 2023-03-09 |
K221816 |
Wesper, Inc.
|
Wesper Lab |
| 2023-02-23 |
K222579 |
Belun Technology Company Limited
|
Belun Sleep System BLS-100 |
| 2023-02-03 |
K222950 |
Acurable Limited
|
AcuPebble OX100 |