Ultraguide , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ultraguide , Ltd.” (first 1998, latest 2002), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 25 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 | 2 |
| HHJ | Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
Most recent Ultraguide , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023227 | USG 2000SA | HHJ | 2002-10-22 | 25 |
| K022354 | ULTRAGUIDE CTG 2000SA | JAK | 2002-08-13 | 25 |
| K013150 | MR-GUIDE 2000 | LNH | 2001-10-18 | 28 |
| K011418 | ULTRAGUIDE MR-GUIDE 3000 | LNH | 2001-05-24 | 15 |
| K002258 | ULTRAGUIDE CT-GUIDE 1010 | JAK | 2000-08-08 | 14 |
| K974432 | ULTRAGUIDE 1000 | IYO | 1998-02-09 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Ultraguide , Ltd..
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 Ultraguide , Ltd. (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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ultraguide , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Ultraguide , Ltd.” (first 1998, latest 2002), across 4 product codes in 2 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 Ultraguide , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ultraguide , Ltd. is 25 days.
Which FDA product codes appear under Ultraguide , Ltd.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 2); LNH (System, Nuclear Magnetic Resonance Imaging, 2); HHJ (Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic, 1).
Next steps
- See all 6 Ultraguide , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Ultraguide , Ltd.'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.