510(k) · Cleared
ClearedManan D Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Technologies, Inc. · EXF Bag, Bile Collecting
Cleared on Jan 30, 1998 as substantially equivalent to K961986 (Manan Medical Products, Inc., 1997) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jan 30, 1998
- Review
- 28 days
- Class
- Class II
- Product code
- EXF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963849 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK963849 Manan D BagManan Medical Products, Inc. · 1996
- This deviceK980005 Manan D BagMedical Device Technologies, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963849 | Manan D Bag | Manan Medical Products, Inc. | 1996 | — |
| 0 (this device) | K980005 | Manan D Bag | Medical Device Technologies, Inc. | 1998 | — |
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 EXF? 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? (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 |
|---|---|---|---|
| * | K961986 | Manan D BagSummary page 1…lecting bag CLASSIFICATION NAME: §876.5010-Biliary Catheters and Accessories SUBSTANTIAL EQUIVALENCE: Company Name Product Name 510(k) No. Manan Medical Products D Bag K961986/K963849 DESCRIPTION OF DEVICE: The Manan D Bag is a 600 ml drainage bag to be used for biliary, nephrostomy and other fluid drai… | 1997 |
| * | K963849 | Manan D BagSummary page 1…bag CLASSIFICATION NAME: §876.5010-Biliary Catheters and Accessories SUBSTANTIAL EQUIVALENCE: Company Name Product Name 510(k) No. Manan Medical Products D Bag K961986/K963849 DESCRIPTION OF DEVICE: The Manan D Bag is a 600 ml drainage bag to be used for biliary, nephrostomy and other fluid drainage pro… | 1996 |
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 EXF devicesEXF Bag, Bile Collecting: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EXF
FDA has decided no EXF device since 2007.
Median 510(k) review, days · EXF
Too few EXF 510(k)s in any year since 2007 to give a median.
Recalls per year · EXF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EXF
2in 2025
MAUDE reports naming product code EXF, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 1 |
| 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 | 6 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Manan™ D Bag is for nephrostomy, abcess and other drainage collection.
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/K980005 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980005: Manan D Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980005
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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