510(k) · Cleared
ClearedRectosight RS 300-04
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sightline Technologies, Ltd. · FER Anoscope And Accessories
Cleared on Jun 30, 2000 after a 206-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 39 later devices descend from it.
- Decided
- Jun 30, 2000
- Review
- 206 days
- Class
- Class II
- Product code
- FER
- Recalls
- None
- Predicates
- 0
39 later devices descend from it, 1 citing it directly.
- This deviceK994130 Rectosight RS 300-04Sightline Technologies, Ltd. · 2000
- Descendant · cites it directly · 38 of its ownK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- Descendant · 2 generations on · 13 of its ownK091305 ClearpathEasyglide, Ltd. · 2009
- Descendant · 2 generations on · 13 of its ownK052930 Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006
- Descendant · 2 generations on · 12 of its ownK070622 Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007
- Descendant · 3 generations on · 10 of its ownK093779 Clearpath UgiEasyglide, Ltd. · 2010
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K032688Colonosight Model 510BSightline Technologies, Ltd. · 2004 · cites it directly38descendants
- K091305ClearpathEasyglide, Ltd. · 2009 · 2 generations on13descendants
- K052930Navigator Endoscopy SystemNeoguide Systems, Inc. · 2006 · 2 generations on13descendants
- K070622Neoguide Endoscopy SystemNeoguide Systems, Inc. · 2007 · 2 generations on12descendants
- K093779Clearpath UgiEasyglide, Ltd. · 2010 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994130 | Rectosight RS 300-04 | Sightline Technologies, Ltd. | 2000 | — |
| +1 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| +2 | K091305 | Clearpath | Easyglide, Ltd. | 2009 | — |
| +2 | K052930 | Navigator Endoscopy System | Neoguide Systems, Inc. | 2006 | — |
| +2 | K070622 | Neoguide Endoscopy System | Neoguide Systems, Inc. | 2007 | — |
| +3 | K093779 | Clearpath Ugi | Easyglide, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FER? 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 FER device
- #1 K250645 SleeveLUX 24 Anoscope/Proctoscope (P2001)…score 10.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (39)
See all 391 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032688 | Colonosight Model 510B | 2004 | 38 |
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?
- Of its descendants, K032688 (Sightline Technologies, Ltd., 2004) has gone furthest, with 38 descendants of its own.
How does its category compare?
All FER devicesFER Anoscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FER
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FER
Too few FER 510(k)s in any year since 2007 to give a median.
Recalls per year · FER
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FER
3in 2025
MAUDE reports naming product code FER, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 1 | 4 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RectoSight® RS 300-04 is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the rectal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures.
The ProctoSight® PS 300-04 is a video sigmoidoscope device intended to provide optical visualization of, and therapeutic access to the anal cavity. The instrument contains channels for insufflation, irrigation and surgical procedures
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994130 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994130: Rectosight RS 300-04.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994130
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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