510(k) · Cleared
ClearedFluid Barrier Boot Knee & Ankle-High
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrument Makar, Inc. · FXP Cover, Shoe, Operating-Room
Cleared on Nov 19, 1996 as substantially equivalent to K914702 (Depuy, Inc., 1993) after a 329-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Nov 19, 1996
- Review
- 329 days
- Class
- Class I
- Product code
- FXP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914702 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK914702 Sterile View (TM) Knee-High Boots/Depuy Shoe BootsDepuy, Inc. · 1993
- This deviceK955835 Fluid Barrier Boot Knee & Ankle-HighInstrument Makar, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914702 | Sterile View (TM) Knee-High Boots/Depuy Shoe Boots | Depuy, Inc. | 1993 | — |
| 0 (this device) | K955835 | Fluid Barrier Boot Knee & Ankle-High | Instrument Makar, 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 FXP? 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? (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 |
|---|---|---|---|
| * | K914702 | Sterile View (TM) Knee-High Boots/Depuy Shoe BootsSummary page 2…y of Safety and Effectiveness The Fluid Barrier Boots, developed by Instrument Makar, Inc., are substantially equivalent to the Sterile View Knee-High Boots from Depuy (K914702) These products compare as shown in the table below. Instrument Makar, Inc. Depuy Fluid Barrier Sterile View Intendoed Usc Pr… | 1993 |
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 FXP devicesFXP Cover, Shoe, Operating-Room: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FXP
FDA has decided no FXP device since 2007.
Median 510(k) review, days · FXP
Too few FXP 510(k)s in any year since 2007 to give a median.
Recalls per year · FXP
No recall names FXP since 2007.
Adverse event reports per year · FXP
35in 2025
MAUDE reports naming product code FXP, 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 | 2 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Fluid Barrier Boot is intended to be used in the hospital environment to provide protection from all types of fluids in the Operating Room, Central Sterile and in the Emergency Room.
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/K955835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955835: Fluid Barrier Boot Knee & Ankle-High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955835
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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