Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Heidelberg Engineering GmbH — Predicate Candidate Screening

17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

147 daysmedian FDA review time
276 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH2026-05-071570
K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH2025-05-12490
K240924AnterionHeidelberg Engineering GmbH2024-12-132530
K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH2024-10-111680
K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH2024-07-011570
K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH2023-10-203290
K230897AnterionHeidelberg Engineering GmbH2023-10-111940
K211817AnterionHeidelberg Engineering GmbH2021-11-051470
K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH2020-09-091210
K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH2019-09-26230
K182569Spectralis HRA+OCT and variants with High Magnification ModuHeidelberg Engineering GmbH2018-10-18300
K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH2018-09-13870
K173648Spectralis HRA + OCT and variantsHeidelberg Engineering GmbH2018-08-302760
K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, SpectrHeidelberg Engineering GmbH2017-11-01570
K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis Heidelberg Engineering GmbH2016-05-062740
K121993SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTHeidelberg Engineering GmbH2012-10-251110
K113129SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)Heidelberg Engineering GmbH2011-11-08150

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda