510(k) Report

FDA applicant

Y

San Diego, CA78 decisions1978–199625 recalls

FDA records 78 decisions for Y (San Diego, CA) from 1978 to 1996: 78 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FRN (Pump, Infusion). 25 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Y’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Y since 2007.

Recalls per year

1in 2023

2007: 12012: 12013: 22014: 22015: 22017: 12018: 22019: 1, 1 Class I2020: 32021: 82023: 1
2007high 8 (2021) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Y by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FPASet, Administration, Intravascular28decisions
  • FRNPump, Infusion26decisions
  • LDRController, Infusion, Intravascular, Electronic8decisions
  • FLLContinuous Measurement Thermometer8decisions
  • KNTTubes, Gastrointestinal (And Accessories)2decisions
  • FPBFilter, Infusion Line1decision

Also: BZT (1), DSK (1), DXN (1), FLN (1), MEA (1).

Who builds on its devices?

Later devices cite its devices 16 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K960280Ivac Needle Free Valve Administration SetsY · 19964cite it
  • K860436Ivac Model 2080 Electronic ThermometerY · 19863cite it
  • K931549Model EZ-1 Sing Chan/EZ-2 Dual Channel Infus PumpY · 19932cite it
  • K811238Model 560 Series Volumetric InfusionY · 19811cites it
  • K852488Controlled Release Infusion System (Cris)Y · 19851cites it
  • K882302Ivac (R) Unvented Vol. Infusion Set Model 52080Y · 19881cites it

What has FDA decided for it lately?

  • K955846Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus Iii Wall Mount ThermometerY · 1996
  • K960280Ivac Needle Free Valve Administration SetsY · 19967 recalls
  • K953225Ivac Ball Valce Admin. SetsY · 1995
  • K934095Ivac Vented Syringe Adapter Administration SetsY · 1994
  • K940897Ivac Needleless Infection Valve Administration SetY · 1994
  • K931550EZ Administration SetY · 19942 recalls
  • K931549Model EZ-1 Sing Chan/EZ-2 Dual Channel Infus PumpY · 19931 recall
  • K932544Ivac Space Saver Volumetric Pump, Model 599Y · 1993

All 78 as Y →

What has been recalled?

25 recalls linked to its devices; the latest:

  • K022209BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS…Oct 11, 2023Class II
  • K780130BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006Aug 2, 2021Class II
  • K960280BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension…Aug 2, 2021Class II
  • K780130BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV…Aug 2, 2021Class II
  • K820278BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163EAug 2, 2021Class II
  • K811885BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF…Aug 2, 2021Class II