Chrysalis Intelligence · Sponsors · Simplivia Healthcare , Ltd.

Simplivia Healthcare , Ltd.

Kiryat Shmona, IL · 6 510(k) clearances · 1 recalls

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Total clearances

6

2020-05-07 → 2025-10-21

Last 12 months

1

Product codes

1

Most recent

2025-10-21

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
ONB	—	—	—	6	2025-10-21

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2022-03-08

Date	Severity	Status	Recall #	Product	Code	Reason
2022-03-08	Class II	Ongoing	Z-1057-2022	OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143	—	Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.

Filings

All 510(k) clearances (6)

Date	K-number	Device	Code	Class	Specialty
2025-10-21	K253033	Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor	ONB	—	—
2025-08-05	K251411	Chemfort Female Luer Lock Adaptor	ONB	—	—
2023-08-02	K231286	Chemfort® Catheter Adaptor	ONB	—	—
2021-09-23	K210707	OnGuard2 Chemfort Closed Administration (CADM)	ONB	—	—
2021-02-25	K201142	TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set	ONB	—	—
2020-05-07	K192866	Chemfort CSTD	ONB	—	—