Instrumentarium Corp.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Instrumentarium Corp.” (first 1983, latest 2002), across 11 product codes in 5 review panels. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 4 | 4 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 4 | 4 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| IZH | System, X-Ray, Mammographic | 2 | 2 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 | 2 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 1 | 1 |
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| FFT | Electrode, Ph, Stomach | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (12)
- Anesthesiology (4)
- Cardiovascular (2)
- Clinical Chemistry (1)
- Gastroenterology and Urology (1)
Most recent Instrumentarium Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022630 | MODIFICATION TO FOCUS | EHD | 2002-10-09 | 63 |
| K001729 | FOCUS | EHD | 2000-07-13 | 36 |
| K001439 | ORTHOCEPH OC100 D | MUH | 2000-06-22 | 45 |
| K992385 | ORTHOPANTOMOGRAPH OP100D | MUH | 1999-09-28 | 74 |
| K981641 | MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ | IZH | 1998-07-17 | 70 |
| K962638 | TONOCAP, TC-200 AND ACCESSORY CATHETERS | CCK | 1997-04-04 | 273 |
| K961441 | TONOMETERED SLAINE BLOOD GAS CONTROL | JJS | 1996-04-30 | 15 |
| K955018 | TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR | FFT | 1996-01-30 | 89 |
| K934478 | ALPHA STEREO | IZH | 1995-01-31 | 504 |
| K923433 | AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE | CBQ | 1993-07-22 | 374 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Instrumentarium Corp..
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 Instrumentarium Corp. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Instrumentarium Imaging, Inc. (24 510(k)s)
- Instrumentarium Dental, Palodex Group OY (5 510(k)s)
- Instrumentarium Corp. Imaging Division (3 510(k)s)
- Instrumentarium Dental, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Instrumentarium Corp.?
FDA lists 20 510(k) clearances under the applicant name “Instrumentarium Corp.” (first 1983, latest 2002), across 11 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 Instrumentarium Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Instrumentarium Corp. is 72 days.
Which FDA product codes appear under Instrumentarium Corp.?
The most frequent FDA product codes under this applicant name are EHD (Unit, X-Ray, Extraoral With Timer, 4); LNH (System, Nuclear Magnetic Resonance Imaging, 4); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 2).
Next steps
- See all 20 Instrumentarium Corp. clearances with predicates and recalls
- Run predicate analysis for product code EHD, Instrumentarium Corp.'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.