MQF · Catheter, Assisted Reproduction · Chrysalis Intelligence

Device class

Class II

Regulation 884.6110

Total clearances

2020-05-01 → 2026-02-12

Last 12 months

Unique sponsors

Classification details

Medical specialty

Obstetrics/Gynecology

Review panel

Regulation number

884.6110

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
Femasys, Inc.	1	0	2023-09-22
Vitrolife Sweden AB	1	0	2025-07-23
Shanghai Horizon Medical Technology Co., Ltd.	1	0	2022-12-16
Allwin Medical Devices, Inc.	1	0	2020-07-01
Kitazato Corporation	1	0	2020-05-01
Guangzhou Hehong Biotech Co., Ltd.	1	1	2026-02-12
Shenzhen Vitavitro Biotech Co., Ltd.	1	0	2024-08-16

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
A4287	HCPCS	Disposable collection and storage bag for breast milk, any size, any type, each ✓ CMS-verified description	Medium	Catheter, assisted reproduction, per catheter

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-02-12	K253354	Guangzhou Hehong Biotech Co., Ltd.	Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
2025-07-23	K243373	Vitrolife Sweden AB	Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
2024-08-16	K240307	Shenzhen Vitavitro Biotech Co., Ltd.	VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
2023-09-22	K231730	Femasys, Inc.	FemaSeed Intratubal Insemination
2022-12-16	K220010	Shanghai Horizon Medical Technology Co., Ltd.	Daylily Single Use Sterile Embryo Transfer Catheter
2020-07-01	K200248	Allwin Medical Devices, Inc.	Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
2020-05-01	K192540	Kitazato Corporation	Kitazato ET Catheters