Chrysalis Intelligence · Sponsors · Recor Medical, Inc.

Recor Medical, Inc.

0 510(k) clearances · 12 PMAs · 2 recalls

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Total clearances

0

None → None

Last 12 months

0

Product codes

0

Most recent

—

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent

Class III

PMA approvals (12)

Total PMA records

12

Originals + supplements

Distinct product codes

1

First decision

2023-11-07

Most recent

2026-08-13

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2026-08-13	P220023-S011	Paradise Ultrasound Renal Denervation System (Paradise System)	Normal 180 Day Track No User Fee	QYI	Ablation Catheter, Renal Denervation	Unknown
2026-07-29	P220023-S012	Paradise Ultrasound Renal Denervation System (Paradise System); Paradise Catheter	30-Day Notice	QYI	Ablation Catheter, Renal Denervation	Unknown
2025-09-11	P220023-S009	ReCor Paradise Catheter	30-Day Notice	QYI	Ablation Catheter, Renal Denervation	Unknown
2025-03-25	P220023-S008	Paradise Ultrasound Renal Denervation System; Paradise Catheter	30-Day Notice	QYI	Ablation Catheter, Renal Denervation	Unknown
2025-03-06	P220023-S007	Paradise Ultrasound Renal Denervation System; Paradise Catheter	30-Day Notice	QYI	Ablation Catheter, Renal Denervation	Unknown
2025-01-24	P220023-S006	Paradise Ultrasound Renal Denervation System (Paradise System), Paradise Catheter	30-Day Notice	QYI	Ablation Catheter, Renal Denervation	Unknown
2024-12-20	P220023-S004	Paradise Ultrasound Renal Denervation System, Paradise Cartridge, Paradise Generator	30-Day Notice	QYI	Ablation Catheter, Renal Denervation	Unknown
2024-12-19	P220023-S005	Paradise Ultrasound Renal Denervation System, Paradise Generator	30-Day Notice	QYI	Ablation Catheter, Renal Denervation	Unknown
2024-10-25	P220023-S003	Paradise® Ultrasound Renal Denervation System	30-Day Notice	QYI	Ablation Catheter, Renal Denervation	Unknown
2024-02-05	P220023-S002	ReCor Paradise® Ultrasound Renal Denervation System	Normal 180 Day Track No User Fee	QYI	Ablation Catheter, Renal Denervation	Unknown
2023-12-06	P220023-S001	Paradise Ultrasound Renal Denervation System (Paradise System), Paradise Cartridge	30-Day Notice	QYI	Ablation Catheter, Renal Denervation	Unknown
2023-11-07	P220023	Paradise® Ultrasound Renal Denervation System	Original	QYI	Ablation Catheter, Renal Denervation	Unknown

Safety

Recalls (2)

Class I (serious)

0

Risk of injury / death

Total recalls

2

Currently ongoing

2

Most recent

2026-01-29

Date	Severity	Status	Recall #	Product	Code	Reason
2026-01-29	Class II	Ongoing	Z-1655-2026	Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS…	—	Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
2026-01-29	Class II	Ongoing	Z-1654-2026	Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS…	—	Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

Filings

510(k) clearances (none indexed)

Date	K-number	Device	Code	Class	Specialty