510(k) · Cleared
ClearedAllegiance Kwik Heat Warm Perineal Pack
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 Nov 13, 1997 as substantially equivalent to K970399 (Allegiance Healthcare Corp., 1997) after a 42-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Nov 13, 1997
- Review
- 42 days
- Class
- Class I
- Product code
- IMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970399 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK970399 Kwik Kold Peri Cold Pack (Catalog Number TBD)Allegiance Healthcare Corp. · 1997
- This deviceK973770 Allegiance Kwik Heat Warm Perineal PackAllegiance Healthcare Corp. · 1997
- Descendant · cites it directly · 1 of its ownK021843 Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK082087 Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970399 | Kwik Kold Peri Cold Pack (Catalog Number TBD) | Allegiance Healthcare Corp. | 1997 | — |
| 0 (this device) | K973770 | Allegiance Kwik Heat Warm Perineal Pack | Allegiance Healthcare Corp. | 1997 | — |
| +1 | K021843 | Eyefeel Ophthalmic Warmer | Bio-Lipid, Inc. | 2002 | — |
| +2 | K082087 | Eyefeel Ophthalmic Warmer | Bio-Lipid, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K970399 | Kwik Kold Peri Cold Pack (Catalog Number TBD)Summary page 2…ETY AND EFFECTIVENESS Manufacturer: Regulatory Affairs Contact Telephone: Date Summary Prepared: Product Trade Name: Common Name: Classification: Predicate Device: (K970399) Preamendment Description: Allegiance Healthcare Corporation Thermal Business Unit 808 Highway 24 West Moberly, Missouri 652… | 1997 |
| * | — | Jack Frost Perineal Pad (Warm) Named without a submission number | |
| * | — | H.M.S.™ Peri Warm™ Perineal Pack Named without a submission number | |
| * | — | Allegiance Preamendment Small Hot Pack Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021843 | Eyefeel Ophthalmic Warmer | 2002 | 1 |
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?
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?
Hot disposable pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces. Also used as a heat therapy pack with an absorbent perineal pad; for use post delivery to absorb lochea while relieving edema and inflammation associated with an episiotomy.
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/K973770 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973770: Allegiance Kwik Heat Warm Perineal Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973770
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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