510(k) · Cleared
ClearedCP&S Instant Cold Pack Limb Kit Transporter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consolidated Products & Services, Inc. · IMD Pack, Hot Or Cold, Disposable
Cleared on Nov 19, 1997 as substantially equivalent to K890553 (Consolidated Products & Services, Inc., 1989) after a 15-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Nov 19, 1997
- Review
- 15 days
- Class
- Class I
- Product code
- IMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890553 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK890553 CP&S Disposable Instant Cold CompressConsolidated Products & Services, Inc. · 1989
- This deviceK974190 CP&S Instant Cold Pack Limb Kit TransporterConsolidated Products & Services, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890553 | CP&S Disposable Instant Cold Compress | Consolidated Products & Services, Inc. | 1989 | — |
| 0 (this device) | K974190 | CP&S Instant Cold Pack Limb Kit Transporter | Consolidated Products & Services, Inc. | 1997 | — |
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 IMD? 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 IMD device
- #1 K221653 InfaTherm Disposable Infant Warming Mattressscore 4.4 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K890553 | CP&S Disposable Instant Cold CompressSummary page 1…02184 Wayne Kritzman October 31, 1997 Instant Cold Pack Limb Kit Transporter Hot/ Cold Disposable Pack (21CFR 890.5710) Disposable Instant Cold Pack (current 510(k) K890553 to be amended). The CP&S Disposable Instant Ice Pack Limb Kit Transporter is an instant ice pack with an added pouch for the ins… | 1989 |
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 IMD devicesIMD Pack, Hot Or Cold, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMD
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · IMD
Too few IMD 510(k)s in any year since 2007 to give a median.
Recalls per year · IMD
4in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMD
66in 2025
MAUDE reports naming product code IMD, 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 | — | 0 | 211 |
| 2008 | 1 | — | 4 | 804 |
| 2009 | 0 | — | 0 | 210 |
| 2010 | 0 | — | 1 | 58 |
| 2011 | 0 | — | 0 | 70 |
| 2012 | 1 | — | 0 | 53 |
| 2013 | 0 | — | 0 | 40 |
| 2014 | 0 | — | 0 | 33 |
| 2015 | 0 | — | 1 | 193 |
| 2016 | 0 | — | 0 | 213 |
| 2017 | 1 | — | 0 | 234 |
| 2018 | 0 | — | 3 | 262 |
| 2019 | 0 | — | 0 | 632 |
| 2020 | 0 | — | 0 | 248 |
| 2021 | 0 | — | 4 | 142 |
| 2022 | 1 | — | 0 | 202 |
| 2023 | 0 | — | 0 | 184 |
| 2024 | 0 | — | 0 | 112 |
| 2025 | 0 | — | 0 | 66 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CP&S Disposable Ice Pack Limb Kit Transporter provides an environment above freezing for a severed body part while being transported to the hospital emergency room or replantation surgery.
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/K974190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974190: CP&S Instant Cold Pack Limb Kit Transporter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974190
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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