510(k) · Cleared
ClearedEndocervical Block Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallach Surgical Devices, Inc. · HEE Set, Anesthesia, Paracervical
Cleared on Jul 12, 2002 as substantially equivalent to K910252 (CooperSurgical, Inc., 1991) and 3 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1977. 1 later device descends from it.
- Decided
- Jul 12, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- HEE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K771203 (1977). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK771203 Disp. Hypodermic NeedleTerumo America, Inc. · 1977 · Recalled
- 1 generation backK012646 Terumo 30 Gauge Hypodermic NeedleTerumo Medical Corp. · 2001
- This deviceK021224 Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK052365 Cervineedle Disposable Cartridge SyringeRocket Medical Plc · 2005
Most influential descendants
Showing 1 of 1 · See all- K052365Cervineedle Disposable Cartridge SyringeRocket Medical Plc · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771203 | Disp. Hypodermic Needle | Terumo America, Inc. | 1977 | 1 |
| −1 | K012646 | Terumo 30 Gauge Hypodermic Needle | Terumo Medical Corp. | 2001 | — |
| 0 (this device) | K021224 | Endocervical Block Needle | Wallach Surgical Devices, Inc. | 2002 | — |
| +1 | K052365 | Cervineedle Disposable Cartridge Syringe | Rocket Medical Plc | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 HEE? 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 |
|---|---|---|---|
| * | K910252 | Potocky Neddle (TM) Disposable Injection NeedleSummary page 2…Code 80 FMI Regulation Number 880.5570 per 21 CFR. Predicate Devices to which we are claiming:substantial eauivalence: 1 Coopersurgical ‘Potocky Needle’, K910252 2. Avid Medical ‘Avid-Nit Cervical Regional Anesthesia Needle’, KO00 117 3. Terumo Medical ‘Terumo 30 Gauge Hypodermic Needle… | 1991 |
| * | K000117 | Avid-Nit Cervical Regional Anesthesia Needle | 2000 |
| * | K012646 | Terumo 30 Gauge Hypodermic Needle | 2001 |
| * | K013293 | Nipro Hypodermic Needle | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052365 | Cervineedle Disposable Cartridge Syringe | 2005 | 0 |
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 25 years and passes through 3 companies; a new generation was cleared every 24.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K052365 (Rocket Medical Plc, 2005) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K910252.
How does its category compare?
All HEE devicesHEE Set, Anesthesia, Paracervical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HEE
FDA has decided no HEE device since 2007.
Median 510(k) review, days · HEE
Too few HEE 510(k)s in any year since 2007 to give a median.
Recalls per year · HEE
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HEE
3in 2022
MAUDE reports naming product code HEE, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This needle is designed for injection of solutions (such as 2% lidocaine with or without 1: 100,000 epinephrine) into the cervix. The application includes local anesthetics such as electro-excision, electro-fulguration, C02 laser excision, and vaporization, and when required, endocervical curettage and cervical biopsies.
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/K021224 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021224: Endocervical Block Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021224
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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