510(k) · Cleared
ClearedBalloon controller PB-30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical Systems U.S.A, Inc. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Dec 15, 2015 as substantially equivalent to K143556 (Fujifilm Medical Systems U.S.A, Inc., 2015) after a 12-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Dec 15, 2015
- Review
- 12 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K993704 (2000). 7 ancestors in all, the oldest K944759 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 3 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 2 generations backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
- 1 generation backK143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015
- This deviceK153483 Balloon controller PB-30Fujifilm Medical Systems U.S.A, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK261880 FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy…Fujifilm Corporation · 2026
Most influential descendants
Showing 1 of 1 · See all- K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −3 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −2 | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 | Fujinon, Inc. | 2009 | — |
| −1 | K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | Fujifilm Medical Systems U.S.A, Inc. | 2015 | — |
| 0 (this device) | K153483 | Balloon controller PB-30 | Fujifilm Medical Systems U.S.A, Inc. | 2015 | — |
| +1 | K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program… | Fujifilm Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 FDF? 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 FDF device
- #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TSummary page 4…n: Colonoscope and Accessories (Flexible/Rigid), 21 C.F.R. § 876.1500 Product Code: FDF, FDA Primary Predicate Fujifilm Balloon Controller PB-20 (K143556) Purpose of the Special 510(k) notice. The PB-30 is a modification to PB-20. Intended Use… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | 2026 | 0 |
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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K261880 (Fujifilm Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K143556.
How does its category compare?
All FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · FDF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDF
194in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDF
8in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDF
17,231in 2025
MAUDE reports naming product code FDF, 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 | 4 | 70 | 0 | 81 |
| 2008 | 2 | — | 0 | 68 |
| 2009 | 6 | 91 | 0 | 83 |
| 2010 | 4 | 101 | 0 | 48 |
| 2011 | 2 | — | 0 | 77 |
| 2012 | 7 | 241 | 0 | 88 |
| 2013 | 2 | — | 0 | 63 |
| 2014 | 6 | 164 | 0 | 60 |
| 2015 | 2 | — | 1 | 100 |
| 2016 | 7 | 98 | 1 | 170 |
| 2017 | 4 | 36 | 0 | 370 |
| 2018 | 7 | 101 | 0 | 388 |
| 2019 | 4 | 56 | 0 | 417 |
| 2020 | 4 | 250 | 1 | 687 |
| 2021 | 3 | 30 | 0 | 2,444 |
| 2022 | 5 | 147 | 0 | 8,345 |
| 2023 | 6 | 203 | 8 | 11,748 |
| 2024 | 2 | — | 0 | 12,128 |
| 2025 | 4 | 194 | 0 | 17,231 |
| 2026 | 5 | 147 | 0 | — |
What is it indicated for?
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153483: Balloon controller PB-30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153483
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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