510(k) · Cleared
ClearedKwik Kold Peri Cold Pack (Catalog Number TBD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corp. · IMD Pack, Hot Or Cold, Disposable
Cleared on Apr 3, 1997 after a 59-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Apr 3, 1997
- Review
- 59 days
- Class
- Class I
- Product code
- IMD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK970399 Kwik Kold Peri Cold Pack (Catalog Number TBD)Allegiance Healthcare Corp. · 1997
- Descendant · cites it directly · 2 of its ownK973770 Allegiance Kwik Heat Warm Perineal PackAllegiance Healthcare Corp. · 1997
- Descendant · 2 generations on · 1 of its ownK021843 Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK082087 Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK072082 Gumease Dental MouthpieceBiomedevice, Ltd. · 2007
Most influential descendants
Showing 4 of 4 · See all- K973770Allegiance Kwik Heat Warm Perineal PackAllegiance Healthcare Corp. · 1997 · cites it directly2descendants
- K021843Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2002 · 2 generations on1descendant
- K082087Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2008 · 3 generations on0descendants
- K072082Gumease Dental MouthpieceBiomedevice, Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970399 | Kwik Kold Peri Cold Pack (Catalog Number TBD) | Allegiance Healthcare Corp. | 1997 | — |
| +1 | K973770 | Allegiance Kwik Heat Warm Perineal Pack | Allegiance Healthcare Corp. | 1997 | — |
| +2 | K021843 | Eyefeel Ophthalmic Warmer | Bio-Lipid, Inc. | 2002 | — |
| +3 | K082087 | Eyefeel Ophthalmic Warmer | Bio-Lipid, Inc. | 2008 | — |
| +1 | K072082 | Gumease Dental Mouthpiece | Biomedevice, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
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? (4)
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 |
|---|---|---|---|
| * | — | Allegiance Peri K™ Perineal Cold Pack Named without a submission number | |
| * | — | Jack Frost Perineal Cold Pack Named without a submission number | |
| * | — | Florida Medical Perineal Cool Comfort Pack Named without a submission number | |
| * | — | Hospital Medical Services Peri + Plus Peri Cold Pack Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K973770 (Allegiance Healthcare Corp., 1997) has gone furthest, with 2 descendants of its own.
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 Allegiance Kwik Kold™ Peri Cold Pack is an over-the-counter, single-use, non-sterile device. It is a cold therapy pack intended to be used post delivery to absorb postpartum lochea while providing cold therapy relieving edema and inflammation associated with an episiotomy incision.
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/K970399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970399: Kwik Kold Peri Cold Pack (Catalog Number TBD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970399
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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