510(k) · Cleared
ClearedPeerscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peermedical · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Sep 28, 2012 as substantially equivalent to K081004 (Stryker GI, 2008) after a 241-day review. Its family tree reaches back 6 generations to 1992. 6 later devices descend from it.
- Decided
- Sep 28, 2012
- Review
- 241 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921244 (1992). 22 ancestors in all, the oldest K822846 (1982). 6 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 5 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 4 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 3 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 2 generations backK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- 1 generation backK081004 Protectiscope CS Colonoscope, Non-IntrapullStryker GI · 2008
- This deviceK120289 Peerscope SystemPeermedical · 2012
- Descendant · cites it directly · 5 of its ownK130718 Peerscope SystemPeermedical, Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK132839 Fuse 1C Colonoscopy SystemEndochoice, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK131422 Peerscope SystemEndochoice, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK152182 Fuse Gastroscopy SystemEndochoice, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK141598 Fuse Colonoscopy SystemEndochoice, Inc. · 2014 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K130718Peerscope SystemPeermedical, Ltd. · 2013 · cites it directly5descendants
- K132839Fuse 1C Colonoscopy SystemEndochoice, Inc. · 2014 · 2 generations on2descendants
- K131422Peerscope SystemEndochoice, Inc. · 2013 · 2 generations on2descendants
- K152182Fuse Gastroscopy SystemEndochoice, Inc. · 2015 · 3 generations on1descendant
- K141598Fuse Colonoscopy SystemEndochoice, Inc. · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −5 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −4 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −3 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −2 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| −1 | K081004 | Protectiscope CS Colonoscope, Non-Intrapull | Stryker GI | 2008 | — |
| 0 (this device) | K120289 | Peerscope System | Peermedical | 2012 | — |
| +1 | K130718 | Peerscope System | Peermedical, Ltd. | 2013 | — |
| +2 | K132839 | Fuse 1C Colonoscopy System | Endochoice, Inc. | 2014 | — |
| +2 | K131422 | Peerscope System | Endochoice, Inc. | 2013 | — |
| +3 | K152182 | Fuse Gastroscopy System | Endochoice, Inc. | 2015 | — |
| +3 | K141598 | Fuse Colonoscopy System | Endochoice, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K081004 | Protectiscope CS Colonoscope, Non-IntrapullSummary page 1…rology/Urology Device Class: 11. Reason for 510(k) Submission: New Device Identification of Legallv Marketed Predicate Devices ProtectiScope CS -K08 1004 - Manufactured by Stryker 01 Device Description The PeerScope system consists of endoscopic Main Control Unit (MCU), and of the P… | 2008 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130718 | Peerscope System | 2013 | 5 |
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 20 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K130718 (Peermedical, Ltd., 2013) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K081004.
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. 2012, 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?
The PeerScope System is intended for diagnostic visualization of the digestive tract.. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The PeerScope System consists of PeerMedical camera heads, endoscopes, video system, light source and other ancillary equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120289 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120289: Peerscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120289
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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