510(k) · Cleared
ClearedTekno-Medical Obstetrical Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tekno Medical Optik-Chirurgie GmbH & Co. · HDA Forceps, Obstetrical
Cleared on Feb 11, 2002 as substantially equivalent to K951529 (Baxter Healthcare Corp, 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Feb 11, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HDA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951529 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK951529 V. Mueller Obstetrical (OB) ForcepsBaxter Healthcare Corp · 1995
- This deviceK013747 Tekno-Medical Obstetrical ForcepsTekno Medical Optik-Chirurgie GmbH & Co. · 2002
- Descendant · cites it directly · 0 of its ownK100517 Instrumed Forceps Obsterical, Model# 46-5XXX, OB-XXXXInstrumed International, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK092827 Dimela Obsterical Forceps, Model 72.1 XX XXDimeda Instrumente GmbH · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951529 | V. Mueller Obstetrical (OB) Forceps | Baxter Healthcare Corp | 1995 | — |
| 0 (this device) | K013747 | Tekno-Medical Obstetrical Forceps | Tekno Medical Optik-Chirurgie GmbH & Co. | 2002 | — |
| +1 | K100517 | Instrumed Forceps Obsterical, Model# 46-5XXX, OB-XXXX | Instrumed International, Inc. | 2010 | — |
| +1 | K092827 | Dimela Obsterical Forceps, Model 72.1 XX XX | Dimeda Instrumente GmbH | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K951529 | V. Mueller Obstetrical (OB) ForcepsSummary page 1…ence: Tekno-medical obstetrical forceps are identical to the V.Mueller obstetrical forceps marketed legally in the U.S. by Baxter Healthcare Corp. with the 510(k) number K951529. The tekno-medical obstetrical forceps have the same components as the before mentioned products. No new materials have been used… | 1995 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HDA devicesHDA Forceps, Obstetrical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Obstetrical forceps are used for helping delivering the baby.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013747: Tekno-Medical Obstetrical Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013747
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026