Chrysalis Intelligence · Product Codes · POV

POV · Unclassified

7 clearances · 3 unique sponsors

Device class
Regulation —
Total clearances
7
2020-10-28 → 2026-04-09
Last 12 months
1
Unique sponsors
3
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
Medical Electronic Systems , Ltd. 3 0 2025-05-02
Bonraybio Co., Ltd. 3 0 2025-05-30
Checkcells, Inc. 1 1 2026-04-09
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
89310 CPT High Semen analysis; presence and/or motility of sperm including Huhner test
89320 CPT High Semen analysis; volume, count, motility, morphology
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-09 K252228 Checkcells, Inc. Seaman Pro/Seaman
2025-05-30 K242830 Bonraybio Co., Ltd. LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
2025-05-09 K242388 Bonraybio Co., Ltd. LensHooke X12 PRO Semen Analysis System
2025-05-02 K243114 Medical Electronic Systems , Ltd. SQA-iOw Sperm Quality Analyzer
2024-11-29 K241628 Medical Electronic Systems , Ltd. YO Home Sperm Test
2023-08-07 K220828 Medical Electronic Systems , Ltd. SQA-iO Sperm Quality Analyzer
2020-10-28 K202089 Bonraybio Co., Ltd. LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer