510(k) · Cleared
ClearedInstrumed Forceps Obsterical, Model# 46-5XXX, OB-XXXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumed International, Inc. · HDA Forceps, Obstetrical
Cleared on Apr 29, 2010 as substantially equivalent to K013747 (Tekno Medical Optik-Chirurgie GmbH & Co., 2002) and 1 other predicate after a 65-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Apr 29, 2010
- Review
- 65 days
- Class
- Class II
- Product code
- HDA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951529 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK951529 V. Mueller Obstetrical (OB) ForcepsBaxter Healthcare Corp · 1995
- 1 generation backK013747 Tekno-Medical Obstetrical ForcepsTekno Medical Optik-Chirurgie GmbH & Co. · 2002
- This deviceK100517 Instrumed Forceps Obsterical, Model# 46-5XXX, OB-XXXXInstrumed International, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951529 | V. Mueller Obstetrical (OB) Forceps | Baxter Healthcare Corp | 1995 | — |
| −1 | K013747 | Tekno-Medical Obstetrical Forceps | Tekno Medical Optik-Chirurgie GmbH & Co. | 2002 | — |
| 0 (this device) | K100517 | Instrumed Forceps Obsterical, Model# 46-5XXX, OB-XXXX | Instrumed International, Inc. | 2010 | — |
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 HDA? 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? (2)
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 |
|---|---|---|---|
| * | K013747 | Tekno-Medical Obstetrical ForcepsSummary page 1…400 Obstetric forceps. Product Code HDA Regulation Description Obstetric-gynecologic specialized manual instrument/forceps Substantial Equivalence Claims: HDA K01 3747 TEKNO-MEDICAL OBSTETRICAL FORCEPS Applicant TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. K951529 V.… | 2002 |
| * | K951529 | V. Mueller Obstetrical (OB) ForcepsSummary page 1…ent/forceps Substantial Equivalence Claims: HDA K01 3747 TEKNO-MEDICAL OBSTETRICAL FORCEPS Applicant TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. K951529 V. MUELLER OBSTETRICAL (OB) FORCEPS Applicant BAXTER HEALTHCARE CORP.… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K013747.
How does its category compare?
All HDA devicesHDA Forceps, Obstetrical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HDA
2in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · HDA
Too few HDA 510(k)s in any year since 2007 to give a median.
Recalls per year · HDA
4in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HDA
9in 2025
MAUDE reports naming product code HDA, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 4 | 30 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 0 | — | 0 | 21 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
INSTRUIMED Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery for the following indications, provided that the fetal head is positioned appropriately in the vagina:
* prolonged second stage
* suspicion of immediate or potential fetal compromise
* shortening of the second stage for maternal benefit
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100517 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100517: Instrumed Forceps Obsterical, Model# 46-5XXX, OB-XXXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100517
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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