SMARTVALVE— 510(k) K974589
Substantially EquivalentIcu Medical, Inc.
FDA 510(k) clearance K974589 for SMARTVALVE, Substantially Equivalent on 1998-01-09. Applicant: Icu Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Icu Medical, Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Clemente, CA, US
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More clearances from Icu Medical, Inc.
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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 K974589
K-number listed on FDA's recall record- Z-0252-2021 — 120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040141(17)250101(30)25(10)4573652. The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as an accessory to Intravascular administration set.
- Z-0257-2021 — 98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709076119(17)250101(30)25(10)4584862. The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as an accessory to Intravascular administration set.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974589.
Data sourced from openFDA. This site is unofficial and independent of the FDA.