Critikon Company, LLC: FDA filings under this applicant name
FDA lists 51 510(k) clearances under the applicant name “Critikon Company, LLC” (first 1979, latest 2000), across 20 product codes in 5 review panels. Median 510(k) review time under this name: 77 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 10 | 10 |
| FRN | Pump, Infusion | 7 | 7 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 6 | 6 |
| FPA | Set, Administration, Intravascular | 4 | 4 |
| DYG | Catheter, Flow Directed | 3 | 3 |
| DPS | Electrocardiograph | 2 | 2 |
| DQA | Oximeter | 2 | 2 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | 2 |
| FPB | Filter, Infusion Line | 2 | 2 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 2 | 2 |
Plus 10 more product codes.
Review panels
- Cardiovascular (24)
- General Hospital (19)
- Anesthesiology (6)
- Gastroenterology and Urology (1)
- Neurology (1)
Most recent Critikon Company, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002248 | DINAMAP PRO 1000 MONITOR, MODEL 1000 | DXN | 2000-09-21 | 58 |
| K000500 | DINAMAP ADVANCED NIBP MODULE | DXN | 2000-05-26 | 102 |
| K992638 | DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 | MWI | 2000-02-24 | 202 |
| K982342 | DINAMAP MPS SELECT PORTABLE MONITOR | MSX | 1998-08-14 | 39 |
| K943709 | DINAMAP PLUS VITAL SIGNS MONOITOR | DPS | 1995-06-16 | 319 |
| K942700 | DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 | MHX | 1995-03-01 | 266 |
| K933404 | CRITIKON CENTRAL STATIN MONITOR | DPS | 1994-02-09 | 212 |
| K933050 | CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH | FOZ | 1993-12-14 | 208 |
| K915697 | CRITIKON VITAL SIGNS MODULE | DXN | 1993-07-01 | 556 |
| K921295 | INTRAVENOUS CATHETERS MODIFICATIONS | FGO | 1993-05-17 | 431 |
41 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Critikon Company, LLC.
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 Critikon Company, LLC (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 Critikon Company, LLC?
FDA lists 51 510(k) clearances under the applicant name “Critikon Company, LLC” (first 1979, latest 2000), across 20 product codes in 5 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 Critikon Company, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Critikon Company, LLC is 77 days.
Which FDA product codes appear under Critikon Company, LLC?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 10); FRN (Pump, Infusion, 7); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 6).
Next steps
- See all 51 Critikon Company, LLC clearances with predicates and recalls
- Run predicate analysis for product code DXN, Critikon Company, LLC'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.