510(k) · Cleared
ClearedDimela Obsterical Forceps, Model 72.1 XX XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dimeda Instrumente GmbH · HDA Forceps, Obstetrical
Cleared on Jan 8, 2010 as substantially equivalent to K013747 (Tekno Medical Optik-Chirurgie GmbH & Co., 2002) and 1 other predicate after a 116-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jan 8, 2010
- Review
- 116 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.
View FIG. 1 as a table
Line of descent and top descendants
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…rceps /K092827 Common name: Obstetrical forceps Classfication name: Obstetric forceps (21 CFR 884.4400, Product code HDA) Substantial Equivalence Obstetrical forceps: K0 13747 - Tekno-Medical Obstetrical Forceps!/ K95 15,29 - V. MUELLER Obstetrical (OR) Forceps Description of the Device: The Dimeda Obs… | 2002 |
| * | K951529 | V. Mueller Obstetrical (OB) ForcepsSummary page 2…, performance, mechanical safety characteristics and partly in terms of sizes to the Tekno-Medical Obstetrical Forceps (K013747) and V. MUELLER Obstetrical (OB) Forceps (K95 1529). There are mainly no differences of the Dimeda Obstetrical Forceps to the predicate devices. By the Dimeda Obstetrical Forceps h… | 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 7.9 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?
The Dimeda Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate vaginal delivery, provided that the cervix is fully dilated and the fetal head is positioned appropriately in the vagina. Use of the forceps is indicated for:
o prolonged second stage
o suspicion of immediate or potential fetal compromise
o shortening of the second stage for maternal benefit
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092827 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092827: Dimela Obsterical Forceps, Model 72.1 XX XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092827
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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