VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE— 510(k) K991088
Substantially EquivalentBecton Dickinson Vacutainer Systems
FDA 510(k) clearance K991088 for VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE, Substantially Equivalent on 1999-05-28. Applicant: Becton Dickinson Vacutainer Systems. Device class: 2.
Clearance details
- Applicant
- Becton Dickinson Vacutainer Systems
- 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
- Franklin Lake, NJ, US
Recent devices under product code JKA
view all- K262242 — Profoject Safe Push Button Blood Collection Sets
- K260857 — Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set
- K252344 — BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)
- K262215 — Profoject Safety Sliding Blood Collection Set
- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
More clearances from Becton Dickinson Vacutainer Systems
view all- K002456 — MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
- K991702 — MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578
- K991120 — VACUTAINER BRAND CTAD TUBE (MULTIPLE)
- K982541 — VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608
- K982922 — VACUTAINER BRAND BLOOD COLLECTION SYRINGE
Adverse 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 K991088
K-number listed on FDA's recall record- Z-0837-2022 — Regard Custom Procedure Kits containing BD Luer Lok Access Devices
- Z-0665-2022 — BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991088.
Data sourced from openFDA. This site is unofficial and independent of the FDA.