Y
Mchenry, IL, US
Y appears in FDA device records in Mchenry, IL. FDA records list 31 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 31
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 31 510(k) clearances for Y between 1978 and 1984. The busiest year on record is 1980, with 8. The most recent is 1984, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 4 |
| 1980 | 8 |
| 1981 | 5 |
| 1982 | 6 |
| 1983 | 4 |
| 1984 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K843185 | IVAC C80014 Y SOLUTION ADMIN. SET | FPA | Substantially Equivalent | |
| K842589 | IVAC KEOFEED HYDROPHILIC FEEDING TUBE | KNT | Substantially Equivalent | |
| K842419 | IVAC 280 VOLUMETRIC INFUSION CONTROLLER | LDR | Substantially Equivalent | |
| K833034 | UNIVERSAL VENTED & NON/VOLUME INFUS- | FPA | Substantially Equivalent | |
| K833033 | INFUSION SET-52-05-1 20 DROPS-MI VOL | FPA | Substantially Equivalent | |
| K823018 | MODEL 460 INTERMITTENT MEDICATION DELIV | FLN | Substantially Equivalent | |
| K823743 | MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO | BZT | Substantially Equivalent | |
| K823035 | COMPUTER INTERFACE MODULE CIM | FRN | Substantially Equivalent | |
| K821047 | IVAC 630 & VOLUMETRIC INFUSION PUMP | FRN | Substantially Equivalent | |
| K820764 | IVAC MODEL 160 AIR-IN-LINE SENSOR | FRN | Substantially Equivalent | |
| K820569 | IVAC #1160 MULTIPLE VITAL SIGNS UNIT | DXN | Substantially Equivalent | |
| K820409 | ELECTRONIC CLINICAL THERMOMETER TEMP PR | FLL | Substantially Equivalent | |
| K820278 | INTRAVASCULAR ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K811885 | 30-30-2 700 SYRINGE EXTENSION SET | FPA | Substantially Equivalent | |
| K811884 | IVAC 700 SYRINGE INFUSION PUMP | FRN | Substantially Equivalent | |
| K811110 | MODELS: 52-01-0, 52-01-1 | FPA | Substantially Equivalent | |
| K811208 | MODEL 1100 SPHYGMOMANOMETER | DSK | Substantially Equivalent | |
| K810295 | COMPUTER INTERFACE MODULE | FRN | Substantially Equivalent | |
| K801930 | IVAC 811Y ELEC. CLINICAL THERMOMETER | FLL | Substantially Equivalent | |
| K801874 | MODEL 86-21-1 260 APPROX. 60 DROPS/VENTD | FPA | Substantially Equivalent | |
| K801873 | MODEL 86-21-0 260 SECONDARY MEDICATION | FPA | Substantially Equivalent | |
| K801872 | MODEL 86-01-1 260 SOLUTION ADMIN. SET | FPA | Substantially Equivalent | |
| K801861 | IVAC 260 SERIES VOLUME TRIC INFUSION CON | LDR | Substantially Equivalent | |
| K801614 | MODEL 40-30-2 AIR ELIMINATING FILTER SET | FPB | Substantially Equivalent | |
| K801613 | MODEL 72-81-0 UNVENTED SOLUTION ADM. SET | FPA | Substantially Equivalent | |
| K800512 | ELECTRONIC CLINICAL THERM. MODEL 811A | FLL | Substantially Equivalent | |
| K791209 | IVAC 819 ELECTRONIC THERMOMETER | FLL | Substantially Equivalent | |
| K791208 | IVAC 833 ELECTRONIC THERMOMETER | FLL | Substantially Equivalent | |
| K790582 | INTRAVASCULAR ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K790373 | IVAC 630 VOLUMETRIC INFUSION PUMP | FRN | Substantially Equivalent | |
| K780130 | BURETTE INTRAVENOUS ADMIN. SETS. | FPA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DSKComputer, Blood-Pressure
- FLLContinuous Measurement Thermometer
- LDRController, Infusion, Intravascular, Electronic
- FPBFilter, Infusion Line
- FLNMonitor, Electric For Gravity Flow Infusion Systems
- FRNPump, Infusion
- FPASet, Administration, Intravascular
- BZTStethoscope, Esophageal, With Electrical Conductors
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain