Chrysalis Intelligence · Product Codes · QRL

QRL · Unclassified

26 clearances · 18 unique sponsors

Device class
Regulation —
Total clearances
26
2022-02-17 → 2026-07-22
Last 12 months
3
Unique sponsors
18
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
Tianjin Huahong Technology Co., Ltd. 4 2 2026-07-22
Facet Technologies, LLC 3 0 2024-01-25
Roche Diabetes Care, Inc. 2 0 2022-04-29
Ascensia Diabetes Care U.S., Inc. 2 0 2025-05-14
SteriLance Medical (Suzhou), Inc. 2 1 2026-07-06
Beijing Ruicheng Medical Supplies Co., Ltd. 1 0 2022-09-07
Owen Mumford, Ltd. 1 0 2022-10-03
Asahi Polyslider Co., Ltd. 1 0 2022-08-23
Tianjin Rilifine Medical Device Co., Ltd. 1 0 2022-11-21
Arkray, Inc. 1 0 2022-10-17
I-Sens, Inc. 1 0 2022-11-23
Shandong Lianfa Medical Plastic Products Co. , Ltd. 1 0 2022-11-30
Medifun Corporation 1 0 2023-11-22
Promisemed Hangzhou Meditech Co., Ltd. 1 0 2023-02-21
Gostar Co., Ltd. 1 0 2023-01-20
Bionime Corporation 1 0 2022-09-26
Suzhou Kyuan Medical Apparatus Co., Ltd. 1 0 2022-08-17
Trividia Health 1 0 2022-10-18
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
A4651 HCPCS Calibrated microcapillary tube, each ✓ CMS-verified description High Lancing device (dialysis), each; reusable blood lancet for single patient use
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-22 K262211 Tianjin Huahong Technology Co., Ltd. Lancet
2026-07-06 K260122 SteriLance Medical (Suzhou), Inc. Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)
2025-12-09 K253706 Tianjin Huahong Technology Co., Ltd. Lancing device (HH-XV-T)
2025-05-14 K250813 Ascensia Diabetes Care U.S., Inc. MICROLET®NEXT 2 Lancing Device
2024-11-15 K243306 Tianjin Huahong Technology Co., Ltd. Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)
2024-01-25 K232912 Facet Technologies, LLC Facet Aurora Reusable Lancet Base
2023-11-22 K231797 Medifun Corporation Medifun Lancing Device, Model No. LD-E1
2023-02-21 K223643 Promisemed Hangzhou Meditech Co., Ltd. Verifine® Ease Lancing Device, Verifine® Lancing Device
2023-01-20 K221419 Gostar Co., Ltd. TD-5010 Lancing Device and TD-5084 Sterile Lancets
2022-11-30 K222472 Shandong Lianfa Medical Plastic Products Co. , Ltd. Lancing System, Sterile Lancet for Single Use, Lancing Device
2022-11-28 K223099 Facet Technologies, LLC Facet Manatee Reusable Lancing Base
2022-11-23 K222656 I-Sens, Inc. LDE4 Lancing Device
2022-11-21 K222246 Tianjin Rilifine Medical Device Co., Ltd. Disposable Sterile Lancet
2022-11-18 K222539 Facet Technologies, LLC Facet Blood Lancets
2022-10-18 K221072 Trividia Health TRUEdraw Lancing Device, Mini Lancing Device
2022-10-17 K221175 Arkray, Inc. Multi-Lancet Device 2, ReliOn Premier Lancing Device
2022-10-03 K221613 Owen Mumford, Ltd. Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
2022-09-26 K221062 Bionime Corporation RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
2022-09-07 K222034 Beijing Ruicheng Medical Supplies Co., Ltd. RightLance Blood Lancing System
2022-08-30 K221970 SteriLance Medical (Suzhou), Inc. Lancing device
2022-08-23 K221546 Asahi Polyslider Co., Ltd. OneTouch Delica Plus Lancing System
2022-08-17 K220387 Suzhou Kyuan Medical Apparatus Co., Ltd. Disposable Blood Lancets
2022-07-06 K220475 Tianjin Huahong Technology Co., Ltd. Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)
2022-06-03 K220633 Ascensia Diabetes Care U.S., Inc. MICROLET NEXT lancing device, MICROLET Lancet
2022-04-29 K220608 Roche Diabetes Care, Inc. Accu-Chek FastClix Blood Lancing System