E-Z-Em, Inc.: FDA filings under this applicant name
FDA lists 56 510(k) clearances under the applicant name “E-Z-Em, Inc.” (first 1977, latest 2007), across 33 product codes in 8 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 4 | 4 |
| FPA | Set, Administration, Intravascular | 3 | 3 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 3 | 3 |
| JAK | System, X-Ray, Tomography, Computed | 3 | 3 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DQX | Wire, Guide, Catheter | 2 | 2 |
| DRC | Trocar | 2 | 2 |
| DSB | Plethysmograph, Impedance | 2 | 2 |
| FGD | Catheter, Retention, Barium Enema With Bag | 2 | 2 |
Plus 23 more product codes.
Review panels
- Gastroenterology and Urology (17)
- Cardiovascular (12)
- General Hospital (8)
- Radiology (5)
- General and Plastic Surgery (4)
- Microbiology (3)
- Obstetrics and Gynecology (3)
- Anesthesiology (1)
Most recent E-Z-Em, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071378 | MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES | JAK | 2007-06-13 | 27 |
| K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | IZQ | 2007-04-13 | 234 |
| K063029 | EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 | JAK | 2006-11-02 | 31 |
| K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR | FCX | 2005-12-27 | 62 |
| K041178 | EMPOWER TRANSFER SET, (CAT. NO. 7725) | FPK | 2004-07-16 | 72 |
| K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | IZQ | 2003-06-19 | 30 |
| K030854 | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 | FCX | 2003-04-16 | 29 |
| K013219 | PROTOCO2L INSUFFLATOR MODEL 6400 | FCX | 2002-02-19 | 146 |
| K011160 | E-Z EM PERCUPUMP 2001 CT INJECTOR | JAK | 2001-05-16 | 30 |
| K974621 | PERCUPUMP II WITH EDA | DSB | 1998-01-27 | 47 |
46 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-12-03.
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 E-Z-Em, Inc. (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 E-Z-Em, Inc.?
FDA lists 56 510(k) clearances under the applicant name “E-Z-Em, Inc.” (first 1977, latest 2007), across 33 product codes in 8 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 E-Z-Em, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name E-Z-Em, Inc. is 86 days.
Which FDA product codes appear under E-Z-Em, Inc.?
The most frequent FDA product codes under this applicant name are FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope, 4); FPA (Set, Administration, Intravascular, 3); HIO (Sampler, Amniotic Fluid (Amniocentesis Tray), 3).
Next steps
- See all 56 E-Z-Em, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FCX, E-Z-Em, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.