510(k) · Cleared
ClearedBrella-Spec (TM) Vaginal Speculum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Proa Medical, Inc. · HIB Speculum, Vaginal, Nonmetal
Cleared on Apr 28, 2014 as substantially equivalent to K072762 (Depalt, Inc., 2008) after a 130-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Apr 28, 2014
- Review
- 130 days
- Class
- Class II
- Product code
- HIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K020726 (2002). 5 ancestors in all, the oldest K941272 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK020726 Dukal Disposable Vaginal Speculum, Small, Medium, and LargeDukal Corp. · 2002
- 2 generations backK052314 Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium…Dynarex Corp. · 2005
- 1 generation backK072762 Depalt Vaginal Specuim and Depalt Lighting SystemDepalt, Inc. · 2008
- This deviceK133857 Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020726 | Dukal Disposable Vaginal Speculum, Small, Medium, and Large | Dukal Corp. | 2002 | — |
| −2 | K052314 | Dynarex Vaginal Specula 4900, Models 4911-Small, 4912-Medium, 4913-Large | Dynarex Corp. | 2005 | — |
| −1 | K072762 | Depalt Vaginal Specuim and Depalt Lighting System | Depalt, Inc. | 2008 | — |
| 0 (this device) | K133857 | Brella-Spec (TM) Vaginal Speculum | Proa Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2007 | 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 HIB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HIB device
- #1 K252208 JFord Speculum Sleeve™score 11.9 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K072762 | Depalt Vaginal Specuim and Depalt Lighting SystemSummary page 2…Tel: (310) 717-5822 Predicate Device a) Depalt Vaginal Speculum 2000 Series and Depalt Lighting Sy stem cleared for marketing under 5 10(k) notification number K072762. Device IDcscription The lBrella-SpeTM Vaginal Speculumn is a sterile, single-use device with built-in LED illumination system… | 2008 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All HIB devicesHIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HIB
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HIB
Too few HIB 510(k)s in any year since 2007 to give a median.
Recalls per year · HIB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIB
3in 2025
MAUDE reports naming product code HIB, 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 | 1 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 10 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 1 | 5 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Brella-Spec Vaginal Speculum is used for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations.
Brella-Spec Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133857: Brella-Spec (TM) Vaginal Speculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133857
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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