IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET— 510(k) K123987
Substantially EquivalentInnovative Medical Technologies, Inc.
FDA 510(k) clearance K123987 for IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET, Substantially Equivalent on 2013-08-27. Applicant: Innovative Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Innovative Medical Technologies, Inc.
- Product code
- Product code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leawood, KS, US
Recent devices under product code JKA
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- K262215 — Profoject Safety Sliding Blood Collection Set
- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
More clearances from Innovative Medical Technologies, Inc.
view allAdverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
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 K123987
K-number listed on FDA's recall record- Z-1217-2019 — Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
- Z-2549-2018 — Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO
- Z-2790-2018 — Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123987.
Data sourced from openFDA. This site is unofficial and independent of the FDA.