Delphi Consulting Group: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Delphi Consulting Group” (first 1996, latest 1999), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 196 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 4 | 4 |
| DQD | Stethoscope, Electronic | 2 | 2 |
Review panels
- Cardiovascular (6)
Most recent Delphi Consulting Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983680 | TRINITY II SINGLE CHAMBER DVT PUMP | JOW | 1999-04-28 | 190 |
| K963957 | TRINITY DVT SYSTEM | JOW | 1997-11-04 | 398 |
| K970014 | TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.) | JOW | 1997-08-06 | 216 |
| K961937 | SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM | DQD | 1996-12-09 | 203 |
| K961301 | E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120 | DQD | 1996-06-11 | 68 |
| K954489 | TRINITY SLEEVE(S) | JOW | 1996-02-22 | 148 |
Recalls
openFDA lists no recalls under a recalling firm named Delphi Consulting Group.
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.
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.
- Delphi Medical Systems (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Delphi Consulting Group?
FDA lists 6 510(k) clearances under the applicant name “Delphi Consulting Group” (first 1996, latest 1999), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Delphi Consulting Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name Delphi Consulting Group is 196 days.
Which FDA product codes appear under Delphi Consulting Group?
The most frequent FDA product codes under this applicant name are JOW (Sleeve, Limb, Compressible, 4); DQD (Stethoscope, Electronic, 2).
Next steps
- See all 6 Delphi Consulting Group clearances with predicates and recalls
- Run predicate analysis for product code JOW, Delphi Consulting Group'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.