DSH · Recorder, Magnetic Tape, Medical

Device class

Class II

Regulation 870.2800

Total clearances

2020-05-01 → 2026-07-09

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.2800

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
Bardy Diagnostics, Inc.	3	0	2023-11-22
LifeLens Technologies, Inc.	2	1	2026-07-09
Aevice Health Pte. , Ltd.	2	0	2025-05-05
iRhythm Technologies, Inc.	2	0	2025-08-15
Wellysis Corp.	2	0	2024-02-16
Atsens Co., Ltd.	2	0	2025-05-02
Strados Labs	2	0	2022-04-27
Edan Instruments, Inc.	1	0	2023-09-25
Somnomedics GmbH	1	0	2023-11-27
Wearlinq, Inc.	1	0	2022-10-20
Icentia, Inc.	1	0	2023-03-22
MEZOO Co., Ltd.	1	0	2024-09-20
Vitalograph , Ltd.	1	1	2025-12-03
Smwmed, Inc.	1	1	2026-04-23
Qardio, Inc.	1	0	2021-02-28
Quanta Computer, Inc.	1	0	2022-08-02
Global Instrumentation, LLC	1	0	2020-12-29
Biotricity	1	0	2020-07-29

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
93005	CPT	—	Medium	Magnetic tape recorder for cardiac tracings and rhythm documentation
A4290	HCPCS	Sacral nerve stimulation test lead, each ✓ CMS-verified description	Low	Ambulatory monitoring equipment supply; generic recorder category

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-09	K260157	LifeLens Technologies, Inc.	LifeLens Physiological Monitor
2026-04-23	K252389	Smwmed, Inc.	Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
2025-12-03	K253293	Vitalograph , Ltd.	VitaloJAK Clinic (Model 7100)
2025-08-15	K243650	iRhythm Technologies, Inc.	Zio® monitor (DFG0001)
2025-05-05	K243603	Aevice Health Pte. , Ltd.	AeviceMD
2025-05-02	K242583	Atsens Co., Ltd.	AT-Patch (ATP-C130/ATP-C70)
2024-09-20	K232670	MEZOO Co., Ltd.	HiCardi+ H100
2024-02-16	K233906	Wellysis Corp.	S-Patch (S-Patch ExL)
2023-11-27	K231104	Somnomedics GmbH	ABPMpro
2023-11-22	K233110	Bardy Diagnostics, Inc.	Carnation Ambulatory Monitor
2023-09-25	K230184	Edan Instruments, Inc.	Holter ECG and ABP System
2023-08-30	K231289	Wellysis Corp.	S-Patch Ex Wearable ECG Patch
2023-07-07	K223382	Aevice Health Pte. , Ltd.	AeviceMD
2023-03-22	K223049	Icentia, Inc.	CardioSTAT® ECG Test Solution
2022-10-20	K214073	Wearlinq, Inc.	eWave Monitor
2022-10-12	K203638	Atsens Co., Ltd.	AT-Patch ECG Analysis System
2022-08-02	K210179	Quanta Computer, Inc.	QOCA Portable ECG Monitoring Device
2022-04-27	K220893	Strados Labs, Inc.	Strados Remote Electronic Stethoscope Platform (RESP)
2021-07-20	K203168	LifeLens Technologies, Inc.	LifeLens Wireless ECG Monitor
2021-05-21	K202359	iRhythm Technologies, Inc.	Zio Monitor
2021-02-28	K201644	Qardio, Inc.	QardioCore
2021-02-05	K210036	Bardy Diagnostics, Inc.	Carnation Ambulatory Monitor (CAM)
2020-12-29	K202456	Global Instrumentation, LLC	M5 Recorder
2020-12-20	K201077	Strados Labs	Strados Remote Electronic Stethoscope Platform (RESP)
2020-07-29	K201040	Biotricity	Bioflux Software II