510(k) · Cleared
Recalled · Class II · 2022Sam Chest Seal with Vavle; Sam Chest Seal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sam Medical Products · NAD Dressing, Wound, Occlusive
Cleared on Mar 3, 2011 as substantially equivalent to K942757 (Asherman Medical Products, LLC, 1994) and 1 other predicate after a 191-day review. Its family tree reaches back 1 generation to 1994. It has been recalled once.
- Decided
- Mar 3, 2011
- Review
- 191 days
- Class
- Class I
- Product code
- NAD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942757 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK942757 Asherman Chest BandageAsherman Medical Products, LLC · 1994
- This deviceK102403 Sam Chest Seal with Vavle; Sam Chest SealSam Medical Products · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942757 | Asherman Chest Bandage | Asherman Medical Products, LLC | 1994 | — |
| 0 (this device) | K102403 | Sam Chest Seal with Vavle; Sam Chest Seal | Sam Medical Products | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 NAD? 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 NAD device
- #1 K254246 LT Antibacterial Foam with Silver Dressingscore 13.5 · 6 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K942757 | Asherman Chest BandageSummary page 1…Chest Seal Common/usual Name: Chest Seal Classification Name: Dressing Wound and Burn Occlusive C. Predicate Device: Asherman Chest Bandage, K(942757 Vaseline Petrolatum Gauze, K(973511 D. Device Description: SAM Chest Seal with Valve The SAM Chest… | 1994 |
| * | K973511 | Kendall Curity Petrolatum GauzeSummary page 1…tion Name: Dressing Wound and Burn Occlusive C. Predicate Device: Asherman Chest Bandage, K(942757 Vaseline Petrolatum Gauze, K(973511 D. Device Description: SAM Chest Seal with Valve The SAM Chest Seal with valve is an adhesive dressing composed of a hydrogel ba… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2022 | Class II | Z-0789-2022 | Process control | Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due… |
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 NAD devicesNAD Dressing, Wound, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NAD
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NAD
Too few NAD 510(k)s in any year since 2007 to give a median.
Recalls per year · NAD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAD
2,619in 2025
MAUDE reports naming product code NAD, 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 | 1 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 1 | 30 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 0 | — | 1 | 63 |
| 2015 | 0 | — | 0 | 251 |
| 2016 | 0 | — | 0 | 106 |
| 2017 | 0 | — | 0 | 134 |
| 2018 | 0 | — | 6 | 1,029 |
| 2019 | 0 | — | 0 | 588 |
| 2020 | 0 | — | 0 | 5,035 |
| 2021 | 0 | — | 0 | 451 |
| 2022 | 0 | — | 1 | 403 |
| 2023 | 0 | — | 0 | 1,619 |
| 2024 | 0 | — | 0 | 1,804 |
| 2025 | 0 | — | 1 | 2,619 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
To be used as an occlusive wound dressing.
To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds, and to be used in emergency situations and to be left in place only while the patient is transported to the hospital.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102403: Sam Chest Seal with Vavle; Sam Chest Seal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102403
Report an extraction error
Are you the manufacturer?
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