CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)

510(k) K170982

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK170982	Date24 Aug 2017Cleared	StatusActive

6 recalls · 6 ongoing · FDA

- Ongoing Z-1667-2025 FDA Class I initiated 10 Apr 2025
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
- Ongoing Z-1681-2025 FDA Class I initiated 10 Apr 2025
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
- Ongoing Z-1662-2025 FDA Class I initiated 10 Apr 2025
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
- Ongoing Z-0466-2025 FDA Class II initiated 26 Jun 2024
The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.
- Ongoing Z-2420-2024 FDA Class I initiated 27 Feb 2024
The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
- Ongoing Z-0963-2023 FDA Class I initiated 9 Dec 2022 on shared 510(k) K170982
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)

510(k) Number: K170982
FDA Product Code: MEA
Models / Variants: CADD®- Solis Ambulatory Infusion Pump with Wireless Communication
CADD®-Solis Infusion Pump, Model 2110
PharmGuard® Administrator Medication Safety Software
CADD® Administration Sets
Wireless Communication Module (CM)