Critikon Company, LLC: FDA clearances and approvals
Critikon Company, LLC has 51 FDA 510(k) clearances (first 1979, latest 2000), across 20 product codes in 5 review panels. Median 510(k) review time: 77 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Critikon Company, LLC's product codes (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 does Critikon Company, LLC have?
Critikon Company, LLC has 51 FDA 510(k) clearances (first 1979, latest 2000), across 20 product codes in 5 review panels.
How long does FDA take to clear Critikon Company, LLC's 510(k)s?
The median time from FDA receipt to decision across Critikon Company, LLC's cleared 510(k)s is 77 days.
What devices does Critikon Company, LLC make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 10); FRN (Pump, Infusion, 7); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 6).
Has Critikon Company, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Critikon Company, LLC. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.