510(k) · Decided
DecidedVital Pak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Signs, Inc. · DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Cleared on Mar 8, 1996 as substantially equivalent to K945455 (Vital Signs, Inc., 1994) after a 102-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Mar 8, 1996
- Review
- 102 days
- Class
- Class II
- Product code
- DXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945455 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK945455 General Anesthesia SystemVital Signs, Inc. · 1994
- This deviceK955417 Vital PakVital Signs, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945455 | General Anesthesia System | Vital Signs, Inc. | 1994 | — |
| 0 (this device) | K955417 | Vital Pak | Vital Signs, Inc. | 1996 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXG device
- #1 K253092 Argos Infinity (Rev. 1.0)score 11.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K945455 | General Anesthesia SystemSummary page 2…] o~ inc. 1947-1.B2 Substantial Equivalence: The Vital Pak is an expansion of the General Anesthesia System (GAS). The GAS was described in the 510(k) K945455 and received FDA clearance on December 23, 1994. Since, the addition of legally marketed devices to the GAS does not either chang… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All DXG devicesDXG Computer, Diagnostic, Pre-Programmed, Single-Function: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXG
290in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXG
8in 2025
MAUDE reports naming product code DXG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 43 |
| 2008 | 5 | 118 | 1 | 37 |
| 2009 | 0 | — | 6 | 8 |
| 2010 | 4 | 282 | 1 | 17 |
| 2011 | 3 | 104 | 0 | 7 |
| 2012 | 2 | — | 0 | 29 |
| 2013 | 3 | 236 | 0 | 23 |
| 2014 | 6 | 290 | 0 | 44 |
| 2015 | 1 | — | 0 | 34 |
| 2016 | 1 | — | 0 | 67 |
| 2017 | 1 | — | 0 | 62 |
| 2018 | 2 | — | 0 | 83 |
| 2019 | 2 | — | 0 | 81 |
| 2020 | 1 | — | 2 | 49 |
| 2021 | 1 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The devices are used during the set-up and performance of anesthesia procedures (e.g., general anesthesia, cardiac anesthetic procedures, etc.) and may, depending on the institutions protocol, be used during the transport to and recovery from the same anesthetic procedure. The Vital Pak is designed to conveniently package together those devices, chosen by each institution, that are legally marketed, and typically and repeatedly used by the anesthesia clinicians.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955417 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955417: Vital Pak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955417
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026