Cimilre Dual Max— 510(k) K260643
Substantially EquivalentCimilre Co., Ltd.
FDA 510(k) clearance K260643 for Cimilre Dual Max, Substantially Equivalent on 2026-08-21. Applicant: Cimilre Co., Ltd.. Device class: 2.
Summary
Cimilre's Cimilre Dual Max is filed under product code HGX, powered breast pumps. The record gives no other model numbers or description.
Class II, 21 CFR 884.5160. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Cimilre filed from Cheonan-Si, Chungcheongnam-Do, South Korea. The decision came 175 calendar days after FDA received it (February 27 to August 21, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Cimilre Co., Ltd.
- Product code
- Product code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cheonan-Si, Chungcheongnam-Do,, KR
Recent devices under product code HGX
view all- K254203 — Wearable Breast Pump (Model S36)
- K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more
- K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
- K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
- K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3)
More clearances from Cimilre Co., Ltd.
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.