510(k) · Decided
DecidedEmergency Relief Kit System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · LRR First Aid Kit With Drug
Cleared on Mar 17, 1997 as substantially equivalent to K952786 (Baxter Healthcare Corp, 1995) after a 161-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Mar 17, 1997
- Review
- 161 days
- Class
- Class N
- Product code
- LRR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952786 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952786 Triflex Sterile Synthetic Examination GlovesBaxter Healthcare Corp · 1995
- This deviceK964029 Emergency Relief Kit SystemBaxter Healthcare Corp · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952786 | Triflex Sterile Synthetic Examination Gloves | Baxter Healthcare Corp | 1995 | — |
| 0 (this device) | K964029 | Emergency Relief Kit System | Baxter Healthcare Corp | 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 LRR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (11)
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 |
|---|---|---|---|
| * | K952786 | Triflex Sterile Synthetic Examination GlovesSummary page 1…ory include the following: 1. Gauze Dressing Class | Exempt 21CFR 878.4450 2. Oval Eye Pad Class | Exempt 21CFR 878.4440 3. Vinyl Gloves Class | 21CFR 880.6250 Baxter K952786 Bulk Non-Sterile 4, Adhesive Tape Class | Exempt 21CFR 880.5240 61 MAR @4 ‘97 1@:84AM QARA SURGICAL K C”o ({OZ&… | 1995 |
| * | — | Gauze Dressing Named without a submission number | |
| * | — | Oval Eye Pad Named without a submission number | |
| * | — | Adhesive Tape Named without a submission number | |
| * | — | Scissors Named without a submission number | |
| * | — | Sterile Saline for Eye Irrigation Named without a submission number | |
| * | — | Metal Extremity Splint Named without a submission number | |
| * | — | Cold Pack Named without a submission number | |
| * | — | Bandage Strips Named without a submission number | |
| * | — | Topical Antiseptic Ointment Named without a submission number | |
| * | — | Alcohol Swab Named without a submission number |
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 LRR devicesLRR First Aid Kit With Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRR
FDA has decided no LRR device since 2007.
Median 510(k) review, days · LRR
Too few LRR 510(k)s in any year since 2007 to give a median.
Recalls per year · LRR
2in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LRR
2in 2025
MAUDE reports naming product code LRR, 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 | 0 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 5 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The Baxter Emergency Relief ™ System consists of color-coded mini first aid kits. Each kit is intended to be used as a basic first aid treatment for various emergency situations, while seeking further professional medical assistance.
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/K964029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964029: Emergency Relief Kit System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964029
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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