FDA product code · Gastroenterology, Urology
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Product code KNS covers Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II device regulated under 21 CFR 876.4300. FDA has cleared 188 devices in this code, 6 of them in the last 12 months. Median review time across the 188 most recent decisions is 78 days. openFDA lists 121 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 876.4300
- Review panel
- Gastroenterology, Urology
- Clearances
- 188
What is happening in KNS right now?
KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1268-2026, Z-1269-2026, Z-1270-2026, Z-1271-2026, Z-1272-2026). Adverse events reported in 2026-03 ran high — 297 reports against an expected 69 to 193 (KNS:MAUDE:2026-03). 1 first-time filer in the last 12 months, Francis Medical, Inc (K252388). The code is crowded, scoring 72 of 100 — 87 companies hold a clearance here and 6 arrived in the last 12 months (KNS:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1268-2026, Z-1269-2026, Z-1270-2026, Z-1271-2026, Z-1272-2026 |
| Adverse-event spike | Serious | KNS:MAUDE:2026-03 |
| New entrant | Worth knowing | K252388 |
| Crowding | Context | KNS:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in KNS?
FDA has cleared 188 devices under product code KNS since the 510(k) programme began in 1976, 6 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260962 | Sphincterotome | Taewoong Medical Co., Ltd. | |
| K252388 | Vanquish Water Vapor Ablation Device | Francis Medical, Inc. | |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation | |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Olympus Medical Systems Corp. | |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | Olympus Medical Systems Corporation | |
| K251104 | SureTome SW Sphincterotome with DomeTip | Wilson-Cook Medical | |
| K251226 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | |
| K250584 | Rezum System | Boston Scientific Corporation | |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. | |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. |
How long does FDA review take for KNS?
The median FDA review time for KNS is 78 days, measured across the 188 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KNS?
openFDA lists 121 recall records against product code KNS. A recall record covers one firm's corrective action and may span many device lots.
Z-1268-2026Open, ClassifiedOlympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Z-1269-2026Open, ClassifiedOlympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Z-1270-2026Open, ClassifiedOlympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Z-1271-2026Open, ClassifiedOlympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Z-1272-2026Open, ClassifiedOlympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Showing the 5 most recently initiated of 121. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KNS?
MAUDE holds 4,238 adverse-event reports naming product code KNS, 1,228 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in KNS unusual?
One month sits above KNS's own expected range: 1 March 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 60 | Insufficient history | No expected range — too little history | |
| 83 | Insufficient history | No expected range — too little history | |
| 78 | Insufficient history | No expected range — too little history | |
| 61 | Insufficient history | No expected range — too little history | |
| 78 | Insufficient history | No expected range — too little history | |
| 79 | Insufficient history | No expected range — too little history | |
| 76 | Insufficient history | No expected range — too little history | |
| 79 | Insufficient history | No expected range — too little history | |
| 84 | Insufficient history | No expected range — too little history | |
| 137 | Insufficient history | No expected range — too little history | |
| 183 | Insufficient history | No expected range — too little history | |
| 125 | Insufficient history | No expected range — too little history | |
| 111 | Insufficient history | No expected range — too little history | |
| 144 | Insufficient history | No expected range — too little history | |
| 93 | Insufficient history | No expected range — too little history | |
| 110 | Insufficient history | No expected range — too little history | |
| 153 | Insufficient history | No expected range — too little history | |
| 105 | Insufficient history | No expected range — too little history | |
| 105 | Insufficient history | No expected range — too little history | |
| 122 | Insufficient history | No expected range — too little history | |
| 146 | Insufficient history | No expected range — too little history | |
| 54 | 65–166 | Below expected (65–166) | |
| 80 | 31–139 | Within expected (31–139) | |
| 90 | 46–139 | Within expected (46–139) | |
| 105 | 48–142 | Within expected (48–142) | |
| 122 | 48–136 | Within expected (48–136) | |
| 147 | 60–148 | Within expected (60–148) | |
| 139 | 104–264 | Within expected (104–264) | |
| 147 | 68–191 | Within expected (68–191) | |
| 177 | 79–204 | Within expected (79–204) | |
| 155 | 83–218 | Within expected (83–218) | |
| 125 | 77–198 | Within expected (77–198) | |
| 148 | 82–215 | Within expected (82–215) | |
| 115 | 94–245 | Within expected (94–245) | |
| 94 | 77–183 | Within expected (77–183) | |
| 297 | 69–193 | Above expected (69–193) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in KNS.
Who has entered KNS in the last year?
One company filed in KNS for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Francis Medical, Inc. | K252388 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in KNS?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KNS?
Across the 188 most recent decisions, these applicants filed most often in KNS.
| Applicant | Recent clearances |
|---|---|
| Wilson-Cook Medical, Inc. | 11 |
| Boston Scientific Corp | 9 |
| Boston Scientific Corporation | 7 |
| Olympus Medical Systems Corp. | 7 |
| Aqua Medical, Inc. | 5 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in KNS file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Boston Scientific Corporation | 17 | 3 |
| Wilson-Cook Medical Inc. | 12 | 2 |
| Olympus Medical Systems Corporation | 10 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch KNS
Get an email the morning anything changes in KNS — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.