510(k) · Cleared
Recalled · Class II · 2013Stryker 1488 HD Video Camera with Infrared Compatibility
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · GCJ Laparoscope, General & Plastic Surgery
Cleared on Dec 16, 2013 as substantially equivalent to K983566 (Stryker Endoscopy, 1999) after a 101-day review. Its family tree reaches back 2 generations to 1995. 80 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 16, 2013
- Review
- 101 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950862 (1995). 80 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK950862 Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format)…Karl Storz Imaging, Inc. · 1995
- 1 generation backK983566 3-Chip Video CameraStryker Endoscopy · 1999 · Recalled
- This deviceK132785 Stryker 1488 HD Video Camera with Infrared CompatibilityStryker Endoscopy · 2013
- Descendant · cites it directly · 76 of its ownK142310 Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy · 2014
- Descendant · 2 generations on · 70 of its ownK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 68 of its ownK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- Descendant · 3 generations on · 44 of its ownK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018
- Descendant · 2 generations on · 34 of its ownK173866 Stryker AIM Light Source and SafeLight cableStryker · 2018
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy · 2014 · cites it directly76descendants
- K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · 2 generations on70descendants
- K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · 3 generations on68descendants
- K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018 · 3 generations on44descendants
- K173866Stryker AIM Light Source and SafeLight cableStryker · 2018 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950862 | Karl Storz Endovision Tricam, Model 20221101 (20221001, Pal Format) Color… | Karl Storz Imaging, Inc. | 1995 | — |
| −1 | K983566 | 3-Chip Video Camera | Stryker Endoscopy | 1999 | 1 |
| 0 (this device) | K132785 | Stryker 1488 HD Video Camera with Infrared Compatibility | Stryker Endoscopy | 2013 | — |
| +1 | K142310 | Stryker Infrared Fluorescence (IRF) Imaging System | Stryker Endoscopy | 2014 | — |
| +2 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | 1 |
| +3 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | — |
| +3 | K182606 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2018 | — |
| +2 | K173866 | Stryker AIM Light Source and SafeLight cable | Stryker | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 11 | 0 |
| 2023 | 14 | 0 |
| 2024 | 9 | 0 |
| 2025 | 10 | 0 |
| 2026 | 13 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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 |
|---|---|---|---|
| * | K983566 | 3-Chip Video CameraSummary page 1…ice: Proprietary Name Stryker Model 888 Video Camera Common Name 3-Chip Video Camera Premarket Notification K983566 Classification Name Laparoscope, General and Plastic Surgery Regulation Number 21 CFR 876.1… | 1999 |
What descends from it? (80)
See all 803 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2013 | Class II | Z-0570-2015 | Device Design | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period |
| Mar 5, 2013 | Class II | Z-0569-2015 | Device Design | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period |
| Mar 5, 2013 | Class II | Z-0571-2015 | Device Design | In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 14.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K142310 (Stryker Endoscopy, 2014) has gone furthest, with 76 descendants of its own.
- 2 other devices also cite its predicate K983566.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The Stryker 1488 HD Video Camera with Infrared Compatibility is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/artOsCope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy. laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted…
Read the full statement (138 words)
The Stryker 1488 HD Video Camera with Infrared Compatibility is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/artOsCope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy. laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal fusion, anterior cruciate7lfigamrent re~onstruction, knee arthroscopy. shoulder arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is inidicated and examination of the evacuated cardiac chamber during p~rfrmance of valve replacement. The users of the Stryker 1488 HD Video Camera with Infrared Capability are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons,'orthopedic surgeons, ENT, surgeons and urologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132785 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132785: Stryker 1488 HD Video Camera with Infrared Compatibility.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132785
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