510(k) · Cleared
Recalled · 2008Reprocessed Hot Biopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NLU Forceps, Biopsy, Electric, Reprocessed
Cleared on Jul 20, 2005 as substantially equivalent to K932790 (Cox Medical Ent., Inc., 1994) and 3 other predicates after a 180-day review. Its family tree reaches back 1 generation to 1986. It has been recalled once.
- Decided
- Jul 20, 2005
- Review
- 180 days
- Class
- Class II
- Product code
- NLU
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 1 generation to K860366 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK860366 Challenger Hot Biopsy ForcepsMicrovasive · 1986
- This deviceK050136 Reprocessed Hot Biopsy ForcepsSterilmed, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860366 | Challenger Hot Biopsy Forceps | Microvasive | 1986 | — |
| 0 (this device) | K050136 | Reprocessed Hot Biopsy Forceps | Sterilmed, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 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 NLU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K932790 | Thermal OptionSummary page 1…he reprocessed hot biopsy forceps are substantially equivalent to: "Thermal Option" Hot Biopsy Forceps (K932790), manufactured by Ballard (formerly Cox); "The Shark" Hot Biopsy Forceps manufactured by Wilson-… | 1994 |
| * | K923470 | Disposable Hot Biopsy ForcepsSummary page 1…0), manufactured by Ballard (formerly Cox); "The Shark" Hot Biopsy Forceps manufactured by Wilson-Cook (K923470); "Radial Jaw" Hot Biopsy Forceps (K860366), manufactured by Microvasive; and "Precisor" Hot Bio… | 1993 |
| * | K860366 | Challenger Hot Biopsy ForcepsSummary page 1…"The Shark" Hot Biopsy Forceps manufactured by Wilson-Cook (K923470); "Radial Jaw" Hot Biopsy Forceps (K860366), manufactured by Microvasive; and "Precisor" Hot Biopsy Forcep… | 1986 |
| * | K905088 | Hot Biopsy ForcepsSummary page 1…dial Jaw" Hot Biopsy Forceps (K860366), manufactured by Microvasive; and "Precisor" Hot Biopsy Forceps (K905088), manufactured by Bard (formerly ESCO). Device Description: The device consists of… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2008 | Not classified | Z-0560-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 4 ancestors has a recall.
How does its category compare?
All NLU devicesNLU Forceps, Biopsy, Electric, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NLU
FDA has decided no NLU device since 2007.
Median 510(k) review, days · NLU
Too few NLU 510(k)s in any year since 2007 to give a median.
Recalls per year · NLU
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLU
1in 2018
MAUDE reports naming product code NLU, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Reprocessed Hot Biopsy Forceps are intended to be used for endoscopic tissue sample acquisition, controlled coagulation/cautery, and sessile polyp removal in the gastrointestinal tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050136 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050136: Reprocessed Hot Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050136
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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