HALO AMBULATORY INFUSION SYSTEM— 510(k) K140783
Substantially EquivalentZyno Medical, LLC
FDA 510(k) clearance K140783 for HALO AMBULATORY INFUSION SYSTEM, Substantially Equivalent on 2014-10-17. Applicant: Zyno Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Zyno Medical, LLC
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Natick, MA, US
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More clearances from Zyno Medical, LLC
view allAdverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K140783
K-number listed on FDA's recall record- Z-1285-2024 — Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
- Z-1286-2024 — Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140783.
Data sourced from openFDA. This site is unofficial and independent of the FDA.