Y: FDA filings under this applicant name
FDA lists 78 510(k) clearances under the applicant name “Y” (first 1978, latest 1996), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 28 | 28 |
| FRN | Pump, Infusion | 26 | 26 |
| FLL | Continuous Measurement Thermometer | 8 | 8 |
| LDR | Controller, Infusion, Intravascular, Electronic | 8 | 8 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 | 1 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 1 | 1 |
| FPB | Filter, Infusion Line | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Y 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955846 | MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER | FLL | 1996-10-01 | 280 |
| K960280 | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS | FPA | 1996-04-04 | 76 |
| K953225 | IVAC BALL VALCE ADMIN. SETS | FPA | 1995-09-27 | 79 |
| K934095 | IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS | FPA | 1994-08-10 | 352 |
| K940897 | IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET | FPA | 1994-06-22 | 118 |
| K931550 | EZ ADMINISTRATION SET | FPA | 1994-01-10 | 287 |
| K932544 | IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599 | FRN | 1993-10-12 | 139 |
| K931549 | MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP | FRN | 1993-10-12 | 197 |
| K922115 | IVAC NEEDLELESS INJECTION VALVE | FPA | 1993-10-12 | 525 |
| K930781 | INFUSION PUMP | FRN | 1993-08-19 | 184 |
68 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Y.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Y (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances are listed under Y?
FDA lists 78 510(k) clearances under the applicant name “Y” (first 1978, latest 1996), across 11 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Y?
The median time from FDA receipt to decision across 510(k)s cleared under the name Y is 60 days.
Which FDA product codes appear under Y?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 28); FRN (Pump, Infusion, 26); FLL (Continuous Measurement Thermometer, 8).
Next steps
- See all 78 Y clearances with predicates and recalls
- Run predicate analysis for product code FPA, Y's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.