Data / Medical devices / Israel / PeriGen Solutions Ltd.
PeriGen Solutions Ltd.: FDA-registered device maker in Rishon LeTziyon Central, Israel, 4 510(k) clearances
PeriGen Solutions Ltd. is registered with the FDA (registration 9615396) in Rishon LeTziyon Central, Israel. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated January 10, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615396
- FEI number
- 3002687025
- Address
- Azriel Rishonim, 10th Floor, Sderot Nim2 Rishon LeTziyon, Rishon LeTziyon Central, Israel, 7510002
- Owner or operator
- PeriGen, Inc. (10030146)
- Roles
- Manufacturer
- First device listed
- August 19, 2009
- Registered through
- 2026
- Brand names listed
- HPC Surveillance and Archival, HPC Workflow Manager, PeriCALM CheckList, PeriCALM Curve, PeriCALM Patterns, PeriCALM Patterns 3, PeriCALM Plus, PeriCALM Tracings and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Monitoring, Perinatal | HGM | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 10, 2025 | K241009 | PeriCALM Patterns 3.0 | HGM | Substantially Equivalent | Perigen, Inc. | accessdata.fda.gov |
| December 22, 2005 | K052715 | CALM CURVE, VERSION 01.00 | HGM | Substantially Equivalent | Lms Medical Systems (Canada), Ltd. | accessdata.fda.gov |
| February 8, 2005 | K040788 | CALM PATTERNS, VERSION 01.00.00 | HGM | Substantially Equivalent | Lms Medical Systems , Ltd. | accessdata.fda.gov |
| July 31, 1998 | K980719 | CALM | HGM | Substantially Equivalent | Lms Medical Systems , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 11, 2005 | 35138 | Not yet classified | Terminated | CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and mate | A deficiency in the software code can, in certain circumstances, cause data for the wrong patient to be displayed in the Tracing Review screen when a user is acknowledging an Alert | accessdata.fda.gov |
Compare with other makers
Updated January 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.