510(k) · Cleared
ClearedCamouflage Cuff Savers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
N.A. Braggs Medical, Inc. · DXQ Blood Pressure Cuff
Cleared on Jul 23, 1997 as substantially equivalent to K912638 (Vital Signs, Inc., 1991) and 1 other predicate after a 292-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jul 23, 1997
- Review
- 292 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912638 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK912638 Blood Pressure CuffsVital Signs, Inc. · 1991
- This deviceK963987 Camouflage Cuff SaversN.A. Braggs Medical, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912638 | Blood Pressure Cuffs | Vital Signs, Inc. | 1991 | — |
| 0 (this device) | K963987 | Camouflage Cuff Savers | N.A. Braggs Medical, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 DXQ? 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 DXQ device
- #1 K254287 Medline Reusable Blood Pressure Cuffscore 13.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K912638 | Blood Pressure CuffsSummary page 2…ained: We claim equivalence to 21 CFR section 870.1120- Blood Pressurc Cuft. Predicate devices 1o which equivalence is claited fisted below. {. Vital Signs Clean Cufl- K912638 2. Critivun Disposables ( no number on record according to the Southcast Region Small Business Office of the I'DA ). 3. Bowen M… | 1991 |
| * | K952825 | Cuff GuardSummary page 2…ufl- K912638 2. Critivun Disposables ( no number on record according to the Southcast Region Small Business Office of the I'DA ). 3. Bowen Mcdical Services Cuff Guard- K952825 10-4 1dentification of the Equivalent Device: We compare the Cull Saver, which is essentially a papur thape, Lo two (2) known… | 1995 |
| * | — | Criticon Disposables 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?
- None of the 2 ancestors has a recall.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXQ
174in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXQ
20in 2025
MAUDE reports naming product code DXQ, 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 | 2 | — | 0 | 3 |
| 2008 | 7 | 118 | 0 | 4 |
| 2009 | 5 | 57 | 0 | 2 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 5 | 121 | 1 | 5 |
| 2012 | 4 | 102 | 0 | 7 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 4 | 105 | 0 | 9 |
| 2015 | 10 | 59 | 0 | 23 |
| 2016 | 4 | 217 | 0 | 50 |
| 2017 | 2 | — | 0 | 67 |
| 2018 | 5 | 225 | 0 | 44 |
| 2019 | 3 | 44 | 0 | 41 |
| 2020 | 3 | 207 | 0 | 5 |
| 2021 | 4 | 105 | 0 | 12 |
| 2022 | 4 | 105 | 0 | 3 |
| 2023 | 5 | 79 | 0 | 20 |
| 2024 | 2 | — | 0 | 15 |
| 2025 | 3 | 174 | 1 | 20 |
| 2026 | 4 | 102 | 0 | — |
What is it indicated for?
The intended use of the Cuff Saver will be to cover all types of blood pressure cuffs and/or cuff bladders prior to the cuff or cuff bladder being applied to the patient. This will protect the patient and the health care worker from overt and covert exposure to soiled or contaminated blood pressure cuffs.
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/K963987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963987: Camouflage Cuff Savers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963987
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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