510(k) · Cleared
ClearedBurlew Infant Hood
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promedic, Inc. · FOG Hood, Oxygen, Infant
Cleared on Jul 15, 1996 as substantially equivalent to K893713 (Nova Health Systems, Inc., 1989) after a 39-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Jul 15, 1996
- Review
- 39 days
- Class
- Class I
- Product code
- FOG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K893713 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK893713 Nova Oxygen TentNova Health Systems, Inc. · 1989
- This deviceK962182 Burlew Infant HoodPromedic, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K893713 | Nova Oxygen Tent | Nova Health Systems, Inc. | 1989 | — |
| 0 (this device) | K962182 | Burlew Infant Hood | Promedic, 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 FOG? 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? (3)
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 |
|---|---|---|---|
| * | K893713 | Nova Oxygen TentSummary page 1…ryden, President Burlew Infant Hood Infant hood 73 BYL or FOG - Infant oxygen tent / hood Subsection 868.5700 Disposable Intant hood with drape Nova Health Systems - K893713 Sunnydale - K# unknown Utah Medical - Disposa-Hood - K# unknown The device indicated for patients who need to be placed in an o… | 1989 |
| * | — | Sunnydale Named without a submission number | |
| * | — | Utah Medical - Disposa-Hood 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 FOG devicesFOG Hood, Oxygen, Infant: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOG
FDA has decided no FOG device since 2007.
Median 510(k) review, days · FOG
Too few FOG 510(k)s in any year since 2007 to give a median.
Recalls per year · FOG
No recall names FOG since 2007.
Adverse event reports per year · FOG
3in 2008
MAUDE reports naming product code FOG, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 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 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device indicated for patients who need to be placed in an oxygen enriched environment.
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/K962182 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962182: Burlew Infant Hood.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962182
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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